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 2018-11-15 for ISE INDIRECT K+ FOR GEN.2 10825441001 manufactured by Roche Diagnostics.
[129177370]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[129177371]
The customer received questionable high ise indirect gen. 2 potassium results for patient sample from the cobas 6000 c501 module serial number (b)(4). The customer suspected an interference with the lithium heparin samples. The initial result from a lithium heparin sample was 8. 08 mmol/l and was reported outside of the laboratory to the doctor. The patient was moved to intensive care. A new (citrated plasma) sample was drawn and the potassium result was 4. 80 mmol/l. A third (lithium heparin) sample was drawn and the result was >10. 0 mmol/l with a data flag. This sample was then tested on a bga (abl 90 flex) and the result was 9. 6 mmol/l. A fourth (citrated plasma) sample was drawn and the result was 3. 7 mmol/l on the cobas c501 analyzer and the result was 3. 7 mmol/l on the abl 90 flex analyzer. On (b)(6) 2018, a fifth (lithium heparin) sample was drawn and the result was 4. 15 mmol/l. There was no allegation of an adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-04327 |
| MDR Report Key | 8074136 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-15 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-15 |
| 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 | ISE INDIRECT K+ FOR GEN.2 |
| Generic Name | ELECTRODE, ION SPECIFIC, POTASSIUM |
| Product Code | CEM |
| Date Received | 2018-11-15 |
| Model Number | NA |
| Catalog Number | 10825441001 |
| Lot Number | S36_2018 |
| Device Expiration Date | 2019-07-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-11-15 |