MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-10 for COBAS 311 04826876001 manufactured by Roche Diagnostics.
[4772864]
The customer alleged they received a questionable tina-quant hemoglobin a1c gen. 2 (hba1c) result for one patient on their c311 analyzer. The customer stated they suspected the hba1c reagent pack was the problem and replaced it. The samples tested in the morning with the sample in question were not repeated, but the samples run in afternoon when the reagent pack was replaced were repeated. This was the only sample in question. The patient's initial hba1c result was 7. 9% and it was reported outside the laboratory. The result was questioned on 09/30/2014 by the physician. The patient told the physician that she had never had a high hba1c result before, so a redraw was made. On (b)(6) 2014, the result from the second sample was 5. 8%. On (b)(6) 2014, the original sample was repeated and the result was 5. 8%. The repeat result was considered correct. There were no adverse events. The hba1c reagent lot number was 69127401 and the expiration date was (b)(6) 2015. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[12383836]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[12405144]
The investigation could not determine a specific root cause. Additional information was requested from the customer but was not provided. Pre- analytical issues were excluded as a cause. Although quality controls were within range on the day of the event, an issue with the reagent cassette could not be excluded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-07779 |
| MDR Report Key | 4162228 |
| Report Source | 05,06 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-10-29 |
| Date of Event | 2014-09-29 |
| Date Mfgr Received | 2014-09-30 |
| Date Added to Maude | 2014-10-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 311 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2014-10-10 |
| Model Number | NA |
| Catalog Number | 04826876001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-10 |