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 2016-05-06 for COBAS E411 SYSTEM manufactured by Roche Diagnostics.
[44571297]
This event occurred in (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[44571298]
The customer stated that they had questionable results for four patient samples tested for prolactin (prl) on an e411 analyzer. Of the four samples, one had an erroneous prl result that was reported outside of the laboratory. The sample initially resulted as 46. 60 ng/ml when tested on the e411 analyzer. The 46. 60 ng/ml result was reported outside of the laboratory to the physician. The sample was then tested in another laboratory using a clia test method, where it resulted as 27. 60 ng/ml on (b)(6) 2016. The 27. 60 ng/ml value was believed to be correct. The patient was not adversely affected. The prl reagent lot number was 184180. The reagent expiration date was asked for, but not provided. The field service engineer did not notice the presence of sample clots or fibrin.
Patient Sequence No: 1, Text Type: D, B5
[45862791]
A specific root cause could not be determined based on the provided information. The patient samples were requested for investigation, but could no longer be provided. It was noted that the customer did not use the polyethylene glycol (peg)-precipitation protocol recommended in product labeling for implausible high results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00604 |
| MDR Report Key | 5636617 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-06 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-03-19 |
| Date Mfgr Received | 2016-04-19 |
| Date Added to Maude | 2016-05-06 |
| 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 E411 SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CFT |
| Date Received | 2016-05-06 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 E411 SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-05-06 |
| Model Number | NA |
| Catalog Number | ASKU |
| 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 | 2016-05-06 |