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 2013-01-11 for OMNI 03337154001 manufactured by Roche Diagnostics.
[10452357]
None of the discrepant results were reported outside the laboratory. As far as the customer knew, there were no adverse events.
Patient Sequence No: 1, Text Type: N, H10
[11493756]
Medwatch (manufacturing site) was updated.
Patient Sequence No: 1, Text Type: N, H10
[17447659]
The customer alleged they received questionable ion selective electrode (ise) sodium and potassium results on their cobas c221 analyzer. The specific date of this event is unclear. The customer stated the analyzer was producing very high potassium results and low sodium results that were reported to the consultant. The customer stated they were able to re-test one sample and the repeat results would be within specification. Specific results were not provided. A field service representative performed a three year preventative maintenance on the analyzer. The analyzer seemed ok and the quality control was correct. On either (b)(6) 2012, the customer stated the issue reoccurred. The customer provided a potassium result of 13 and a sodium result of 131, units of measure were not provided. It is unknown if either result was reported outside the laboratory. The customer stated they could not rule out that the patients received treatment based on the discrepant results, but there were no reports of any adverse events. The sodium and potassium electrode lot numbers and expiration dates were not provided. The customer thought the discrepant results were due to a potential blockage at the fill port in conjunction with poor operator handling and potentially forceful injecting of the sample.
Patient Sequence No: 1, Text Type: D, B5
[17756618]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00253 |
| MDR Report Key | 2911533 |
| Report Source | 01,05,06 |
| Date Received | 2013-01-11 |
| Date of Report | 2014-02-03 |
| Date of Event | 2012-12-19 |
| Date Mfgr Received | 2012-12-19 |
| Date Added to Maude | 2013-01-11 |
| 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 | OMNI |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2013-01-11 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| 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 | 2013-01-11 |