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 2017-11-01 for ROCHE OMNI S 03337154001 manufactured by Roche Diagnostics.
[91924638]
(b)(6). (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[91924639]
The customer complained of erroneous high results for 1 patient tested for potassium (k) on a cobas b 221 instrument. The initial k result from the b 221 instrument used in the laboratory was 15. 80 (unit of measure not provided). The same sample was run on a different b 221 instrument in the intensive care unit and the result was 3. 90. A new sample was obtained from the patient approximately 1 hour later and the k result on the b 221 instrument in question was 18. 73. This sample was run again on the different b 221 instrument in the intensive care unit and the result was 3. 96. There was no allegation that an adverse event occurred. The k electrode lot number and expiration date were not provided. Calibration was acceptable prior to the event. Quality controls (qc) passed the morning of the event. It was noted that ise electrodes were changed on (b)(6) 2017, but the k electrode was not changed until after this event. The customer stated they had trouble with "glu" and "lac" recently. Hb derivatives were calibrated and all was ok afterwards. The customer stated the k electrode was full of fluid; the k electrode was reinserted and qc was fine. K results were intermittently high for some patients. The customer also received errors on the instrument so the customer deproteinized the instrument. Qc was acceptable afterwards. A different patient was tested for k on the b 221 instrument and the results compared well to one another so the customer thought the issue was fixed. Preventive maintenance was performed on (b)(6) 2017. The patient in question was tested on the b 221 instrument again and the k results had "settled down. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02502 |
| MDR Report Key | 6993685 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-01 |
| Date of Report | 2018-04-04 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2017-10-16 |
| Date Added to Maude | 2017-11-01 |
| 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 | 2017-11-01 |
| Model Number | NA |
| Catalog Number | 03337154001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | NURSE |
| 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 | 2017-11-01 |