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 2017-08-17 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[83750603]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[83750604]
The customer received questionable elecsys total psa immunoassay and/or elecsys free psa immunoassay result for two patient samples. Of the data provided, only the following results were discrepant. Patient 1 initial total psa result was >100 ng/ml. The repeat result with a 1:5 dilution was 48. 76 ng/ml. The repeat result with no dilution was >100 ng/ml and the repeat result with a 1:2 dilution was 140 ng/ml. Patient 2 initial free psa result was 0. 003 ng/ml. The repeat result was 0. 5 ng/ml. This patient was male. No erroneous result was reported outside the laboratory. There was no allegation of an adverse event. The total psa reagent lot number was 19942201 with an expiration date of 04/30/2018. The free psa reagent lot number was 15099000 with an expiration date of 08/31/2017. The field service representative adjusted the mixer speed because he found it was creating foam in the reagents and he adjusted the position of the probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01726 |
| MDR Report Key | 6800054 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-27 |
| Date Mfgr Received | 2017-07-27 |
| Date Added to Maude | 2017-08-17 |
| 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 | LTJ |
| Date Received | 2017-08-17 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-17 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-08-17 |