MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-03 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[89620191]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[89620192]
The customer complained of discrepant elecsys brahms pct (pct) result for one patient sample. The initial pct result was 0. 110 ng/ml. This result was reported outside of the laboratory. The initial result was questioned so a repeat test was ordered. The repeat pct result was >100 ng/ml, with a data flag. Repeat testing was performed on another analyzer and deemed to be correct. There was no adverse event from the initial result being reported out. Qc results prior to the event were acceptable. The pct reagent lot was 24279802 with an expiration date of 30-sep-2018. The field engineering specialist was not able to reproduce the error or find a root cause. He checked the fluidics and mechanical adjustments. He performed precision and performance testing which all passed. Further investigation could not determine a root cause. A historical query for this site was performed and no new or past escalated complaints of this nature on any like instruments were found for the past 12 months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02184 |
| MDR Report Key | 6911540 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-03 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-03 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | PMT |
| Date Received | 2017-10-03 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-10-03 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-10-03 |