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Terminated

One Touch Ping Insulin Pump using ezManager Max diabetes management software

FDA Recall Z-1560-2010 · Posted 2010-05-08

Recalling FirmAnimas Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2009-12-18
Date Terminated2010-06-22
Product Quantity21 pumps

Reason for Recall

Software malfunction which disallows users to download, view and print information from their pump (including blood glucose, insulin delivery, carbohydrate and pump events). Additionally, users are unable to customize the built-in food database and pump settings using the software.

Firm Action

The recalling firm telephoned the patients/users to inform them of the problem. A letter dated 12/22/09 was also sent to users. Users will have a replacement unit sent to them so that they will be able to fully utilize the pump and the software. As a courtesy a letter dated 12/22/09 was issued to the health care provider/prescribing physician for the affected users.

Root Cause

Software design

Distribution Pattern

The pumps were provided to patients/users in CA, CT, FL, GA, ID, MA, MO, NJ, OH, OR, PA, TX, and WA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEMAnimas Corp. · 2008-06-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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