MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-10 for A1CNOW SELFCHECK 3030 manufactured by Bayer Healthcare Llc.
[3726368]
The customer ran a test on the a1cnow kit and received a reading of 5. 2%. He then ran another test on a second a1cnow kit with a reading of 7. 2%. The difference between the tests could be clinically significant. The customer declined replacement product and did not provide further information before disconnecting the call.
Patient Sequence No: 1, Text Type: D, B5
[11090173]
The second a1cnow lot# involved: 1300767, exp 11/08/2014. The manufacture date 05/08/2013. The call ended before the customer's personal information was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1826988-2013-00425 |
| MDR Report Key | 3338621 |
| Report Source | 04 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-08-11 |
| Date Mfgr Received | 2013-08-12 |
| Device Manufacturer Date | 2012-09-24 |
| Date Added to Maude | 2013-12-09 |
| 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 | 0 |
| 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 |
| 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 | 2013-09-10 |
| Model Number | 3030 |
| Lot Number | 1303729 |
| Device Expiration Date | 2014-12-24 |
| 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 | 2013-09-10 |