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 2017-08-04 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[82581317]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[82581318]
The customer complained of a low erroneous result for 1 patient sample tested for elecsys prolactin assay (prolactin) on a cobas e 411 immunoassay analyzer. The initial result was 0. 076 ng/ml. This result was reported outside of the laboratory. The sample was repeated and the result was 15. 55 ng/ml. This result was also reported outside of the laboratory. Quality control (qc) results were within the acceptable range. There was no allegation that an adverse event occurred. The prolactin reagent lot number was 17223700 with an expiration date of 03/31/2018. The customer noted that there was a sample noise alarm at the same time this sample was pipetted and is wondering why there was no instrument alarm produced with the low result. The customer also stated there was wet serum on the wall of the sample container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01602 |
| MDR Report Key | 6767508 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-04 |
| Date of Report | 2017-09-12 |
| Date of Event | 2017-07-12 |
| Date Mfgr Received | 2017-07-14 |
| Date Added to Maude | 2017-08-04 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CFT |
| Date Received | 2017-08-04 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-04 |
| Model Number | E411 RACK |
| Catalog Number | 04775201001 |
| 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 | 2017-08-04 |