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 2019-05-30 for COBAS 8000 COBAS ISE MODULE COBAS 8000 ISE 05964075001 manufactured by Roche Diagnostics.
[146515277]
The field service engineer determined that the dilution nozzle was loose and misadjusted. He adjusted the dilution nozzle and ran ise checks. No errors were received. The customer ran calibration and controls successfully. All results were within the customer's established ranges. The customer ran correlation studies comparing results with another system; the results matched, with no errors. The investigation determined the issue was resolved by these service actions.
Patient Sequence No: 1, Text Type: N, H10
[146515278]
The initial reporter stated that they received discrepant results for one patient sample tested with ise indirect na, k, ci for gen. 2 and a second patient sample tested for na on a cobas 8000 ise module. Incorrect results for these samples were reported outside of the laboratory. The repeat results were believed to be correct. The customer also stated that they were receiving ise noise errors on the analyzer which started on (b)(6) 2019. The first sample initially resulted with an na value of 169 mmol/l accompanied by a data flag. The sample was repeated on the same analyzer, resulting with an na value of 146 mmol/l. When repeated on a second analyzer, the na value was 144 mmol/l. The sample initially resulted with a k value of 4. 8 mmol/l, which repeated as 4. 0 mmol/l when tested on the second analyzer. The sample initially resulted with a cl value of 88 mmol/l, which repeated as 104 mmol/l when tested on the second analyzer. The second sample initially resulted with an na value of 174 mmol/l, which repeated as 141 mmol/l. The patients were not adversely affected. The na electrode lot number was q6849, the k electrode lot number was x9499, and the cl electrode lot number was g2859. The electrode expiration dates were asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-02013 |
| MDR Report Key | 8654065 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-30 |
| Date of Report | 2019-05-30 |
| Date of Event | 2019-05-11 |
| Date Mfgr Received | 2019-05-11 |
| Date Added to Maude | 2019-05-30 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 8000 COBAS ISE MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2019-05-30 |
| Model Number | COBAS 8000 ISE |
| Catalog Number | 05964075001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-30 |