MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2013-07-31 for A1CNOW SELFCHECK 3026 manufactured by Bayer Healthcare Llc.
[3674945]
A pharmacist from (b)(6) had tested his blood on the a1cnow selfcheck kit and received readings of 6. 5 and 6. 8%, which he felt was too high. No adverse event was alleged. The complaint did not meet the criteria to be reported at the time of the call, but the kit was returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[11060793]
Three monitors and five cartridges were received and tested by qa: monitor "a" had only one historical reading of 7. 2%. Monitors "b" and "c" had no successful readings. Bio-rad lyphochek control was run on the returned product and the readings were 0. 6 and 0. 4% high out of spec. Retention lot was also tested with the control and the readings were 0. 2%, with level 1, and 1. 7% ,with level 2, high out of spec. The issue if being investigated. In some countries outside the us, customer information is not provided due to privacy laws.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1826988-2013-00363 |
| MDR Report Key | 3256461 |
| Report Source | 01,05 |
| Date Received | 2013-07-31 |
| Date of Report | 2013-07-01 |
| Date of Event | 2013-07-01 |
| Date Mfgr Received | 2013-07-01 |
| Device Manufacturer Date | 2012-04-17 |
| Date Added to Maude | 2013-10-25 |
| 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 | 2013-07-31 |
| Returned To Mfg | 2013-07-01 |
| Model Number | 3026 |
| Lot Number | 1127668 |
| Device Expiration Date | 2013-07-17 |
| Operator | PHARMACIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-07-31 |