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 2016-03-28 for COBAS 8000 E602 MODULE 05990378001 manufactured by Roche Diagnostics.
[41264418]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[41264419]
The customer stated that they received an erroneous result for one patient sample tested for ferritin on an e602 analyzer. The sample initially resulted as 1. 19 ug/l and this value was reported outside of the laboratory to the physician. The physician did not trust the result and asked for the sample to be repeated. The sample was repeated on the same analyzer, resulting as 20. 17 ug/l. The sample was also repeated on an e170 analyzer, resulting as 18. 46 ug/l. The repeat result was believed to be correct. The patient was not adversely affected. The ferritin reagent lot number was 121669. The reagent expiration date was asked for, but not provided. The field service engineer found that reagent cups on the analyzer were dirty. He cleaned the cups and performed a measuring cell preparation. He checked sample adjustment and this was ok. He did not detect any other issues with the system. He ran performance testing. He stated that the overall cleanliness of the laboratory was good.
Patient Sequence No: 1, Text Type: D, B5
[43655135]
It was stated that the performance testing run on the analyzer was successful. A specific root cause could not be determined based on the provided information. A general reagent or instrument issue could not be seen.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00351 |
| MDR Report Key | 5529344 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-28 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-03-08 |
| Date Mfgr Received | 2016-03-15 |
| Date Added to Maude | 2016-03-28 |
| 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 | JMG |
| Date Received | 2016-03-28 |
| Model Number | NA |
| 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 | 2016-03-28 |
| Model Number | NA |
| 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 | 2016-03-28 |