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 2017-09-21 for COBAS 6000 E 601 MODULE E601 manufactured by Roche Diagnostics.
[89358143]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89358144]
The customer complained of an erroneous high result for 1 patient sample tested for elecsys total psa immunoassay (total psa) on a cobas 6000 e 601 module. Weekly maintenance was performed on (b)(6) 2017. Quality controls (qc) were high after maintenance. Qc was repeated and was within the expected target. No more qc was run for the remainder of the day. During validation delta checks, erroneous results were identified. The initial total psa result was 5. 19 ng/ml. This result was reported outside of the laboratory. On (b)(6) 2017 the sample was repeated and the result was 0. 692 ng/ml. The repeat result was believed to be correct based on the patient? S medical history. There was no allegation that an adverse event occurred. The total psa reagent lot number was 216023 with an expiration date of 30-jun-2018. The customer noted there were a few fibrin strands visible in the original sample. The customer complained of qc issues with other assays as well. Calibration signals were found to be slightly low however; there is no indication of a reagent issue. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Possible root causes may be related to preanalytic issues such as clotting time or visible fibrin strands. Additional possible root causes for this event may be insufficient electromagnetic interference lab compliance, sample quality, insufficient maintenance, or contamination of the environment with the analyte.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02032 |
| MDR Report Key | 6882226 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-08-30 |
| Date Added to Maude | 2017-09-21 |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2017-09-21 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-21 |
| Model Number | E601 |
| Catalog Number | ASKU |
| 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 | 2017-09-21 |