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 2018-09-14 for ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 manufactured by Roche Diagnostics.
[120398827]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[120398828]
The customer complained of discrepant ise indirect na for gen. 2 results for 1 patient sample on a roche 9180 electrolyte analyzer compared to an elyte instrument. The na result was 132 mmol/l on the 9180 electrolyte analyzer. The na result was 141 mmol/l on the elyte instrument. There was no allegation of an adverse event. No erroneous results were reported outside of the laboratory. The customer performed daily maintenance and calibration. The customer repeated the sample. The repeat na result was 137 mmol/l on the 9180 electrolyte analyzer and 142 mmol/l on the elyte instrument. The na electrode lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03149 |
| MDR Report Key | 7877768 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-14 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-08-28 |
| Date Mfgr Received | 2018-08-28 |
| Date Added to Maude | 2018-09-14 |
| 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 | 2018-09-14 |
| Model Number | ISE 9180 |
| Catalog Number | ASKU |
| 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 | 2018-09-14 |