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 2018-08-06 for ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 03157334001 manufactured by Roche Diagnostics.
[116872936]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[116872937]
The customer stated that they received an erroneous result for one patient sample tested for potassium on a roche 9180 electrolyte analyzer. The sample resulted with a potassium value of 6. 7 mmol/l when tested on the 9180. The sample was repeated on an istat analyzer, resulting as 4. 6 mmol/l. Both values were reported outside of the laboratory to the doctor. No adverse events were alleged to have occurred with the patient. The potassium electrode lot number and expiration date were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02623 |
| MDR Report Key | 7752893 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-06 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-07-20 |
| Date Mfgr Received | 2018-07-20 |
| Date Added to Maude | 2018-08-06 |
| 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 INSTRUMENT CENTER AG TEGIMENTA |
| Manufacturer Street | FORRENSTRASSE NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE 9180 ELECTROLYTE ANALYZER |
| Generic Name | ELECTROLYTE ANALYZER |
| Product Code | JFP |
| Date Received | 2018-08-06 |
| Model Number | ISE 9180 |
| Catalog Number | 03157334001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-08-06 |