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 2017-09-11 for ISE INDIRECT NA, K, CI FOR GEN.2 COBAS 8000 ISE 03149501001 manufactured by Roche Diagnostics.
[86455671]
Unique identifier (udi)# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86455672]
The customer complained of questionable results for ise indirect na and ci for gen. 2 for one patient sample. Of the data provided only the result for chloride is a reportable malfunction. The initial chloride result was 71 mmol/l with a repeat result of 106 mmol/l. The repeat testing was performed on the other ion selective electrode unit on the same cobas 8000 cobas ise module (double) system. The repeat result was deemed to be correct. The initial chloride result was reported outside of the laboratory. There was no adverse event. The lot number and expiration date for the chloride electrode was requested but not provided. The sample was processed by a modular pre-analytics system. The field engineering specialist found buildup around the mixing vessel. He cleaned the buildup that he found along the mixing vessel, along with the cleaning and checking of other components. He ran precision checks which were acceptable. The customer ran calibration and qc which all passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01948 |
| MDR Report Key | 6854831 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-11 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-09-11 |
| 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 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 NA, K, CI FOR GEN.2 |
| Generic Name | REFERENCE ELECTRODE |
| Product Code | CGZ |
| Date Received | 2017-09-11 |
| Model Number | COBAS 8000 ISE |
| Catalog Number | 03149501001 |
| 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 | 2017-09-11 |