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 2016-01-08 for COBAS 8000 E602 MODULE 05990378001 manufactured by Roche Diagnostics.
[35490923]
This event occurred in (b)(6). (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[35490924]
The customer received a questionable results for igg antibodies to cytomegalovirus (cmv igg). The initial result was 11. 95 u/ml and was reported outside the lab. A new sample collected on (b)(6) 2015 had a result of 0. 2 u/ml. A backup sample from (b)(6) 2015 was then tested and the result was 0. 2 u/ml. The patient was not adversely affected. The reagent lot number was 185518. The expiration date was requested, but was not provided. Field service checked the system for half year maintenance.
Patient Sequence No: 1, Text Type: D, B5
[36974953]
A specific root cause could not be identified. A sample pipetting issue could be excluded. A carryover issue in the measuring cell caused by a temporary blockage of the sipper flow path by a clot or a defect of the pinch valve tube was the most likely cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00016 |
| MDR Report Key | 5356024 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-08 |
| Date of Report | 2016-01-27 |
| Date of Event | 2015-12-02 |
| Date Mfgr Received | 2015-12-22 |
| Date Added to Maude | 2016-01-08 |
| 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 |
| 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 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LIN |
| Date Received | 2016-01-08 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 E602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-01-08 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2016-01-08 |