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 2017-07-31 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK 04775201001 manufactured by Roche Diagnostics.
[81497343]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[81497344]
The customer stated that they received questionable results for four patient samples tested for the elecsys afp assay (afp) and papp-a elecsys (pappa) on a cobas e 411 immunoassay analyzer (e411). Neither the papp-a reagent nor a similar reagent is available for distribution in the united states. Of the four samples, one sample had an erroneous afp result. The erroneous result was not reported outside of the laboratory. The sample initially resulted as 1. 07 ug/l. The sample was repeated on (b)(6) 2017, resulting as 98. 47 ug/l accompanied by a data flag. The sample was of good quality and there was no foam on the sample surface. No adverse events were alleged to have occurred with the patient. The afp reagent lot number was 17674700, with an expiration date of 10/31/2017. The field service engineer checked the customer's water quality and the analyzer liquid level detection voltage. He performed checks of the analyzer, ran performance testing, and ran blank cell calibration. Performance testing showed no issues. Precision studies were performed and were okay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01571 |
| MDR Report Key | 6755012 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-31 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-06-29 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-07-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CDZ |
| Date Received | 2017-07-31 |
| 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 | 2017-07-31 |
| 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 | 2017-07-31 |