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 2017-02-10 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[67280690]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67280691]
The customer stated that they received erroneous results for two patient samples tested for the elecsys ca 15-3 ii assay (ca 15-3) and the elecsys total psa immunoassay (tpsa) on a cobas 6000 e 601 module (e601). The erroneous results were reported outside of the laboratory. It was stated that the low results did not fit the clinical picture of the patients. The first sample initially resulted as > 100 ng/ml for tpsa on (b)(6) 2016. The sample was diluted 1:10 and repeated, resulting as 0. 53 ng/ml. The second sample, from a (b)(6) female born on (b)(6) 1955, initially resulted as 1. 00 u/ml accompanied by a data flag for ca 15-3 on (b)(6) 2017. The sample was repeated, resulting as 24. 51 u/ml for ca 15-3 on (b)(6) 2017. The patients were not adversely affected. The ca 15-3 reagent lot number was 161228. The tpsa reagent lot number was 135984. The expiration dates for these reagents were asked for, but not provided. No crystals were found in the system reagent cups and the mixer was found to be within specifications. Calibrations were within acceptable limits and controls were within specifications. Samples were tested from primary tubes which were processed on a cobas p612 pre-analytics system.
Patient Sequence No: 1, Text Type: D, B5
[69974237]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested but not provided. The investigation found no other cases for the same incident within the last six months. Possible root causes for this event may be insufficient electromagnetic interference compliance, sample quality, improper handling of the reagent or system reagents, insufficient maintenance, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00270 |
| MDR Report Key | 6321967 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-10 |
| Date of Report | 2017-03-13 |
| Date of Event | 2016-11-16 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-10 |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | MOI |
| Date Received | 2017-02-10 |
| Model Number | E601 |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-02-10 |
| Model Number | E601 |
| 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 | 2017-02-10 |