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 |