FDA Adverse Event
Malfunction
Summary report: N
ONETOUCHPING GLUCOSEMGMTSYSTEM
MDR report key: 3953039
·
Received July 23, 2014
Report
- Report Number
- 2531779-2014-21130
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Report Date
- July 10, 2014
- Manufacturer
- ANIMAS CORPORATION
- Product Code
- LZG
- PMA / PMN Number
- K080639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXAMINED AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TOWARD THE GRIP PAD. DURING TESTING, THE PUMP WAS ABLE TO POWER ON WITHOUT ISSUES. UNRELATED TO THE BATTERY COMPARTMENT ISSUE, THE BOLUS BUTTON COVER WAS OBSERVED TO BE DETACHED FROM THE PUMP. (B)(6).
Description of Event or Problem · 1
THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND FOUND THAT THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION COMPLETED ON (B)(4) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431058 | ONETOUCHPING GLUCOSEMGMTSYSTEM | INSULIN INFUSION PUMP | LZG | ANIMAS CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR |