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 2018-02-28 for ROCHE OMNI ELECTRODE POTASSIUM 03111628180 manufactured by Roche Diagnostics.
[101470650]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101470651]
The customer complained of high results for different patients tested for roche omni electrode potassium (potassium) on a cobas b 221 system. The customer provided an example of an erroneous result for 1 patient where the initial potassium result from a whole blood sample tested on the b 221 system was 12. 64 mmol/l. This result was reported outside of the laboratory. A serum sample measured at the same time on the cobas 8000 analyzer was 4. 4 mmol/l. There was no allegation that an adverse event occurred. The b 221 system serial number was (b)(4). The customer had unspecified qc issues. The customer was advised to replace the potassium electrode and the reference electrode. The customer thinks the potassium electrode was the cause of the issue. The potassium electrode was requested for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00598 |
| MDR Report Key | 7302242 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-28 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-02-04 |
| Date Mfgr Received | 2018-02-09 |
| Date Added to Maude | 2018-02-28 |
| 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 ELECTRODE POTASSIUM |
| Generic Name | ELECTRODE, ION SPECIFIC, POTASSIUM |
| Product Code | CEM |
| Date Received | 2018-02-28 |
| Returned To Mfg | 2018-04-14 |
| Model Number | NA |
| Catalog Number | 03111628180 |
| Lot Number | 21572047 |
| ID Number | NA |
| Device Expiration Date | 2017-11-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-02-28 |