MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-02-28 for A1CNOW SELFCHECK manufactured by Bayer Healthcare Llc.
[17612112]
A customer ran a blood test on the a1cnow and received a reading of 7. 9%. The lab reading was 9. 8%. The difference could be clinically significant. No adverse event was alleged. No additional information was provided. Product was not replaced.
Patient Sequence No: 1, Text Type: D, B5
[17717062]
The initial reporter phone and address were not provided. The customer product information could not be obtained. It's not possible to determine the manufacture date without the product information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1826988-2014-00055 |
| MDR Report Key | 3653578 |
| Report Source | 04 |
| Date Received | 2014-02-28 |
| Date of Report | 2014-02-08 |
| Date of Event | 2014-02-01 |
| Date Mfgr Received | 2014-02-08 |
| Date Added to Maude | 2014-03-19 |
| 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 | 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 |
| 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 | 2014-02-28 |
| 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 | 2014-02-28 |