MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-16 for A1CNOW SELFCHECK 3024 manufactured by Bayer Healthcare Llc.
[3805569]
The customer received a blood test result of 6. 7% from an hba1c test at the lab. He retested on the a1c now system and received 8. 1%. The difference between the readings could be clinically significant. No adverse event was alleged. The customer was advised to return the kit for evaluation. A replacement was sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1826988-2013-00456 |
| MDR Report Key | 3349521 |
| Report Source | 04 |
| Date Received | 2013-09-16 |
| Date of Report | 2013-08-28 |
| Date of Event | 2013-08-01 |
| Date Mfgr Received | 2013-08-28 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-12-20 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROGER SONNENBURG |
| Manufacturer Street | 430 W. BEIGER ST. |
| Manufacturer City | MISHAWAKA IN 46544 |
| Manufacturer Country | US |
| Manufacturer Postal | 46544 |
| Manufacturer Phone | 5742563441 |
| Manufacturer G1 | BAYER HEALTHCARE LLC |
| Manufacturer Street | 510 OAKMEAD PKWY |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | A1CNOW SELFCHECK |
| Generic Name | AT-HOME A1C SYSTEM |
| Product Code | NGB |
| Date Received | 2013-09-16 |
| Model Number | 3024 |
| Lot Number | 1303739 |
| Device Expiration Date | 2014-05-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYER HEALTHCARE LLC |
| Manufacturer Address | 430 S. BEIGER ST. MISHAWAKA IN 46544 US 46544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-16 |