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 2017-10-23 for COBAS 8000 COBAS ISE MODULE COBAS 8000 ISE manufactured by Roche Diagnostics.
[90791938]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90791939]
The customer stated that they received an erroneous result for one patient sample tested for ise indirect k for gen. 2 (potassium) on a cobas 8000 ise module. A sample from the patient initially resulted with a potassium value of 4. 09 mmol/l and this value was reported outside of the laboratory. Another tube collected from the patient at the same time was tested and resulted as 4. 77 mmol/l on (b)(6) 2017. The second measurement result was not reported outside of the laboratory. No adverse events were alleged to have occurred with the patient. The potassium electrode lot number and expiration date were asked for, but not provided. As the time difference between the two measurements was approximately four hours, it was believed that the difference in results was due to the this time difference as the potassium concentration became elevated during storage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02398 |
| MDR Report Key | 6968388 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-09-25 |
| Date Mfgr Received | 2017-10-02 |
| Date Added to Maude | 2017-10-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | CEM |
| Date Received | 2017-10-23 |
| Model Number | COBAS 8000 ISE |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2017-10-23 |