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 2014-04-08 for COBAS B 221<6>=ROCHE OMNI S6 SYSTEM 03337154001 manufactured by Roche Diagnostics.
[4328486]
The customer alleged they received questionable ion selective electrode potassium results on their b221 analyzer. The customer confirmed that over the weekend, there had been some occurrences of discrepant potassium results on their b221, but was unsure of the specifics. The customer provided a potassium result of 6 mmol/l obtained on the b221 analyzer. The customer stated the laboratory result was then returned as 4 mmol/l. The customer also provided data for 1305 potassium results. Information on whether any of the results were from the same patient was requested but not provided. Information on whether any of the results were from the same sample was requested but not provided. Information on whether the discrepant results were reported outside the laboratory was requested but not provided. Information on whether any of the patients were adversely affected was requested but not provided. The specific date of this event was requested but not provided. The potassium electrode lot number and expiration date were requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[11909675]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[12044138]
A root cause could not be determined with the information provided. Additional data were requested but not provided. The provided data revealed no issue regarding the potassium electrode. All calibrations and quality control measurements were within the specification. The potassium electrode was not available for further investigation. The customer stated they assumed the cause of the high potassium results was due to hemolysis of the samples.
Patient Sequence No: 1, Text Type: N, H10
[19455750]
The field service representative went on site. The analyzer was shown to have no issues. The field service representative and customer assumed the discrepant results were due to hemolysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-02491 |
| MDR Report Key | 3734170 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-08 |
| Date of Report | 2014-06-10 |
| Date of Event | 2014-03-16 |
| Date Mfgr Received | 2014-03-16 |
| Date Added to Maude | 2014-04-08 |
| 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 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 DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| 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 | 2014-04-08 |
| 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 | 2014-04-08 |