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 2017-11-14 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[93106774]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[93106775]
The customer complained of erroneous results for 1 patient sample tested for elecsys total psa immunoassay (total psa) on a cobas 8000 e 602 module. The initial total psa result was 11 ng/ml. This result was reported outside of the laboratory where it was questioned by the physician. The sample was repeated on the same instrument and the result was 0. 04 ng/ml. The sample was also repeated on a 2nd e602 module and the result was 0. 04 ng/ml. The results of 0. 04 ng/ml were believed to be correct. The customer doesn? T believe the patient received any treatment based on the initial result released from the laboratory. The physician stated the patient was under a cursory review and the results were being reviewed but no action had been taken yet. There was no allegation that an adverse event occurred. The total psa reagent lot number was 21602700. The expiration date was not provided. The field service engineer (fse) visited the customer site and did not identify an issue. An analyzer baseline check was performed and no abnormalities were noted. Instrument tests passed. The customer ran quality controls within the acceptable ranges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02603 |
| MDR Report Key | 7029016 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-14 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-11-14 |
| 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 | 0 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2017-11-14 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |