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 2017-09-05 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK manufactured by Roche Diagnostics.
[85648415]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[85648416]
The customer received questionable elecsys probnp ii immunoassay results after preventive maintenance was performed on the analyzer. A calibration was performed after the maintenance and qc passed, but was biased low. Patient samples were then tested. Later, the customer attempted to recalibrate the assay, but the calibration failed. A low signal was noted on the calibration so the customer performed multiple measuring cell preparations. The field service representative changed the measuring cell, but realized there was a problem with the bead mixer not turning. A type of belt had been installed on the bead mixer which was thicker and harder. The issue was resolved by replacing the belt and ensuring it was placed properly. Calibration and qc were then acceptable. Of the data provided for six patient samples, only the results for one patient were discrepant. The initial result was 6. 00 pg/ml and the repeat result was 1701 pg/ml. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was not provided. There was no allegation of an adverse event. The reagent lot number was 209223. The expiration date was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01890 |
| MDR Report Key | 6841441 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-05 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2017-08-16 |
| Date Added to Maude | 2017-09-05 |
| 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 | NBC |
| Date Received | 2017-09-05 |
| Model Number | E411 RACK |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-05 |
| Model Number | E411 RACK |
| 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 | 2017-09-05 |