MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-09-19 for COBAS INTEGRA 400 PLUS manufactured by Roche Diagnostics.
[3812946]
The customer received a questionable hemoglobin a1c result for one patient sample. The initial result was 11. 5 % and was reported outside the laboratory. The clinician did not believe the result and asked for repeat resting. On (b)(6) 2013, the sample was repeated and the result was 5. 5%. The patient was not adversely affected. The hemoglobin a1c reagent lot number was 67203301. The expiration date was requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[11290156]
No information was provided on the specific part number involved in this event. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[11608103]
The investigation could not determine a specific root cause. The area around the probe washing station was dirty which could have led to some kind of carry over. As part of comprehensive system maintenance, the field service engineer could not find any problem. He replaced b and c syringes, waste pump and all solenoid valves at the transfer head. No further issues were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05753 |
| MDR Report Key | 3356455 |
| Report Source | 01,05,06 |
| Date Received | 2013-09-19 |
| Date of Report | 2014-01-28 |
| Date of Event | 2013-08-23 |
| Date Mfgr Received | 2013-09-04 |
| Date Added to Maude | 2013-09-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | PDJ |
| Date Received | 2013-09-19 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2013-09-19 |