MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2015-07-20 for COBAS INTEGRA (800) HBA1C DEDICATED 04559126001 manufactured by Roche Diagnostics.
[6029305]
The customer received a questionable hemoglobin a1c result for one patient sample. The initial result was 9. 3% and was reported outside the laboratory. At the request of the customer's client, the sample was repeated on another integra analyzer on (b)(6) 2015 with a result of 6. 4%. On (b)(6) 2015, the original sample and a second sample from the same draw were repeated on another integra analyzer and the results were both 6. 6%. This result was believed to be correct. The patient was not adversely affected. The reagent lot number was 60450401 with an expiration date of 01/31/2016. The field service representative could not determine a cause. He inspected the syringe assembly and probes for any defects, but none were found. He performed sample and reagent probe throughput checks and performed a check test which passed.
Patient Sequence No: 1, Text Type: D, B5
[14242486]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[24989660]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03832 |
| MDR Report Key | 4927033 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2015-07-20 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-06-25 |
| Date Mfgr Received | 2015-07-08 |
| Date Added to Maude | 2015-07-20 |
| 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 | 3 |
| 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 | ROCHE INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA (800) HBA1C DEDICATED |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2015-07-20 |
| Model Number | NA |
| Catalog Number | 04559126001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | COBAS INTEGRA (800) HBA1C DEDICATED |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-07-20 |
| Model Number | NA |
| Catalog Number | 04559126001 |
| 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 | 2015-07-20 |