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 2018-03-02 for ROCHE OMNI ELECTRODE POTASSIUM 03111628180 manufactured by Roche Diagnostics.
[101702100]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101702101]
On (b)(6) 2018, the customer stated that they have had 5 instances where patient samples had high results when tested with roche omni electrode potassium (k+) on a cobas b 221<6>=roche omni s6 system (b221) over the previous two to three weeks. The customer provided data for three patients and of these, two had erroneous results reported outside of the laboratory for k+. A sample from the first patient initially resulted as 5. 26 mmol/l accompanied by a data flag. The sample was repeated on the same analyzer, resulting as 5. 37 mmol/l. The sample was repeated on a second b221 analyzer, resulting as 3. 56 mmol/l. On (b)(6) 2018, a sample from the second patient resulted with a value around 12 or 13 mmol/l. A second sample was collected from the patient and tested, resulting as around 11 mmol/l. This second sample was repeated on a second b221 analyzer, resulting as 3 or 4 mmol/l. No adverse events were alleged to have occurred with the patients. The b221 analyzer serial number was (b)(4). The samples were tested with different k+ electrodes. The electrode used to run the sample from the first patient has been provided for investigation.
Patient Sequence No: 1, Text Type: D, B5
[132919788]
The available electrode provided for investigation was tested. Investigations of the electrode determined that it was operating within the specified accuracy and trueness range. The customer's issue was not duplicated and the electrode is considered to be performing as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2018-00639 |
| MDR Report Key | 7310730 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-02 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-02-12 |
| Date Mfgr Received | 2018-02-13 |
| Date Added to Maude | 2018-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-03-02 |
| Returned To Mfg | 2018-03-01 |
| Model Number | NA |
| Catalog Number | 03111628180 |
| Lot Number | 21573447 |
| ID Number | NA |
| Device Expiration Date | 2018-02-23 |
| 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 | 2018-03-02 |