MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-12-14 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[95856671]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[95856672]
The customer had an intermittent issue with high potassium results from the cobas b 221 in the emergency department when compared to the result for a sample from the patient tested in the laboratory. The customer audited their potassium results and found 11 samples with a potassium result >7 mmol/l from the cobas b221 but a normal result from the laboratory. In most cases, the samples were separate collections at different time points. Two examples were provided where the samples were collected at the same time. Patient 1: the result from the cobas b221 at 10:22 was 8. 57 mmol/l and the result from the laboratory was 4. 4 mmol/l. The repeat result from the cobas b221 at 10:45 was 8. 06 mmol/l and the repeat laboratory result was 4. 3 mmol/l. Patient 2: on (b)(6) 2017, the result from the cobas b221 was 10. 07 mmol/l and the result from the laboratory was 5. 1 mmol/l. The erroneous results were reported outside of the laboratory. There was no allegation of an adverse event. The potassium lot number and expiration date were requested but were not provided. As the potassium results were high and the calcium results were normal for the patients, contamination by k-edta was suspected. As part of troubleshooting, proficiency samples were tested on the suspect and other blood gas analyzers at the site and no discrepancies were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02933 |
| MDR Report Key | 7117656 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-14 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-11-13 |
| Date Mfgr Received | 2017-12-01 |
| Date Added to Maude | 2017-12-14 |
| 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 | 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 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 | ROCHE OMNI S |
| Generic Name | BLOOD GAS ANALYZER |
| Product Code | JJC |
| Date Received | 2017-12-14 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-14 |