MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-26 for ONETOUCHPING GLUCOSEMGMTSYSTEM OTP GLUCOSE MGMT SYSTEM manufactured by Animas Corporation.
[2843482]
On (b)(6) 2012 the reporter contacted animas to report the pump would not power on after it had been exposed to water in a swimming pool. The reporter noted there was moisture in the battery compartment and behind the display lens. There was no damage to the battery compartment or the battery cap, and the battery cap was secure and tight. There was no patient injury associated with this issue.
Patient Sequence No: 1, Text Type: D, B5
[10056999]
The pump has not been returned to animas for evaluation. Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release. If the device is returned, an evaluation shall be completed and a supplemental report will be filed. No conclusions can be made at this time.
Patient Sequence No: 1, Text Type: N, H10
[20396524]
(b)(4): visual inspection revealed a battery compartment crack and corrosion inside the battery compartment. The pump fails to power on, and therefore testing could not be adequately completed. Leak testing revealed a battery compartment leak, and there was evidence of moisture damage found inside the pump. The user guide warns that cracks, chips, or damage to the pump may impact the battery contact and/or the waterproof feature of the pump. Additionally, owner's booklet instructs the user to call animas customer service if the user suspects that the product is damaged.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2531779-2012-07201 |
| MDR Report Key | 2671838 |
| Report Source | 04 |
| Date Received | 2012-07-26 |
| Date of Report | 2012-07-02 |
| Date of Event | 2012-07-02 |
| Date Mfgr Received | 2012-07-02 |
| Device Manufacturer Date | 2010-06-29 |
| Date Added to Maude | 2012-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KELLY STONE |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 193803428 |
| Manufacturer Country | US |
| Manufacturer Postal | 193803428 |
| Manufacturer Phone | 4089564746 |
| Manufacturer G1 | ANIMAS CORPORATION |
| Manufacturer Street | 200 LAWRENCE DR |
| Manufacturer City | WEST CHESTER PA 19380342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 3428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONETOUCHPING GLUCOSEMGMTSYSTEM |
| Generic Name | INSULIN INFUSION PUMP |
| Product Code | LZG |
| Date Received | 2012-07-26 |
| Returned To Mfg | 2012-08-03 |
| Model Number | OTP GLUCOSE MGMT SYSTEM |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANIMAS CORPORATION |
| Manufacturer Address | 200 LAWRENCE DR WEST CHESTER PA 19380342 US 19380 3428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-26 |