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 2013-08-21 for COBAS B 221<6>=ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[3712304]
The customer alleged they received questionable bilirubin results on their b221 analyzer for one patient. The patient's first bilirubin result from a whole blood sample on the b221 analyzer was 726 umol/l accompanied by a data flag. When the doctor reviewed the result, he requested a new blood sample be drawn. The bilirubin result from the new whole blood sample on the b221 analyzer was 728 umol/l accompanied by a data flag. A blood sample taken at the same time as the patient's second sample was tested on an olympus au 640. The bilirubin result was 273 umol/l and it was reported outside the laboratory. The patient was not adversely affected by this event. The bilirubin reagent lot number and expiration date were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[11071869]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[11083038]
A root cause could not be determined. The quality control results before and after the event were all ok. An investigation of the logfiles found no analyzer related reason for the event.
Patient Sequence No: 1, Text Type: N, H10
[11609695]
Medwatch (manufacturing site) was updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-05045 |
| MDR Report Key | 3299500 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-21 |
| Date of Report | 2014-02-03 |
| Date of Event | 2013-07-11 |
| Date Mfgr Received | 2013-07-26 |
| Date Added to Maude | 2013-08-21 |
| 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 B 221=ROCHE OMNI S6 SYSTEM |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2013-08-21 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | PHYSICIAN |
| 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 | 2013-08-21 |