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 2017-08-22 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.
[84082610]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[84082611]
The customer stated that they noticed questionable results for some patient samples tested for alb2 albumin gen. 2 (alb) on the cobas 8000 c (701) module - c701. This prompted them to repeat 1000 patient samples. The customer provided data for two patient samples that were questioned. Of these, one had an erroneous result. The erroneous result was not reported outside of the laboratory. The customer also stated that they were seeing erratic behavior for the enzymatic creatinine test run on the other disk of the analyzer. No further details were provided regarding this. The sample initially resulted with an alb value of 58. 6 g/l. The sample was repeated on (b)(6) 2017, resulting as 39. 3 g/l. The sample was also repeated on (b)(6) 2017, resulting as 40. 8 g/l. No adverse events were alleged to have occurred with the patient. The customer ran precision studies. The customer changed all reagent and sample probes. These actions did not resolve the issue. The field service engineer checked washing on the analyzer and this was ok. He checked gear pump pressure and probe washing and these were ok. He checked the high concentration vacuum and pressure was a bit low. He replaced a valve and damaged tubing. Calibration and quality controls were ok. The issue was due to aging of the replaced valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01788 |
| MDR Report Key | 6809926 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-22 |
| 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 | 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 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CJW |
| Date Received | 2017-08-22 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |
| Brand Name | COBAS 8000 C (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-22 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| Lot Number | NA |
| ID 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 | 2017-08-22 |