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 2018-06-05 for ROCHE 9180 ELECTROLYTE ANALYZER 03107019001 manufactured by Roche Diagnostics.
[110044477]
Unique identifier (udi)# (b)(4). The event occurred in: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[110044478]
The customer received questionable ise indirect na for gen. 2 results for 3 patient samples on a roche 9180 electrolyte analyzer ((b)(4)) compared to two cobas 6000 c (501) modules. Of the data provided, there were discrepant sodium results for 2 patient samples. Patient 1 ise 9180 sodium results were 156 mmol/l with a repeat result of 157 mmol/l. The sodium results from one c501 were 166 mmol/l with a repeat result of 163 mmol/l. The sodium results from the other c501 were 161 mmol/l with a repeat result of 161 mmol/l. Patient 2 ise 9180 sodium results were 143 mmol/l with a repeat result of 143 mmol/l. The sodium results from one c501 were 149 mmol/l with a repeat result of 145 mmol/l. The sodium results from the other c501 were 146 mmol/l with a repeat result of 146 mmol/l. The erroneous results from the (b)(4) were not reported outside of the laboratory. The results from the cobas c501 analyzer were reported outside of the laboratory. There was no allegation of an adverse event. The field engineering specialist tested both the ise high and the ise low calibrators on the two cobas c501s compared to the (b)(64. The cobas c501 results were higher that the (b)(4). The reference electrode was exchanged without any improvement to the situation. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01732 |
| MDR Report Key | 7568510 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-05 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-04-09 |
| Date Mfgr Received | 2018-05-17 |
| Date Added to Maude | 2018-06-05 |
| 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 |
| 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 | 2018-06-05 |
| Model Number | 03107019001 |
| Catalog Number | 03107019001 |
| Lot Number | NA |
| ID 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 | 2018-06-05 |