MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-17 for ROCHE 9180 ELECTROLYTE ANALYZER ISE 9180 03157334001 manufactured by Roche Diagnostics.
[123946079]
Patient Sequence No: 1, Text Type: N, H10
[123946080]
The customer received questionable calcium results from the electrolyte analyzer 9180 that would be 10x the normal result. One example was provided. The results for one sample were 0. 44 mmol/l, 0. 44 mmol/l and 4. 68 mmol/l. The result of 0. 44 mmol/l was believed to be correct. No erroneous result was reported outside of the laboratory. There was no allegation of an adverse event. All qc results were in the acceptable range. The customer replaced all the electrodes, all tubing, and snapack. However, the issue was not resolved. The customer then changed the calcium electrode and ran a 20 specimen validation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-03711 |
| MDR Report Key | 7973214 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-17 |
| Date of Report | 2018-12-14 |
| Date of Event | 2018-09-28 |
| Date Mfgr Received | 2018-09-28 |
| Date Added to Maude | 2018-10-17 |
| 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 | 2018-10-17 |
| 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 | 2018-10-17 |