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 2017-11-14 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.
[93105782]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93105783]
The customer received a questionable low elecsys free psa immunoassay result for one patient sample. The initial result was 0. 014 ng/ml and the repeat result was 0. 278 ng/ml. The sample was repeated on another analyzer and the result was 0. 395 ng/ml. It was unknown if the erroneous result was reported outside of the laboratory. Clarification was requested but was not provided. There was no allegation of an adverse event. The reagent lot number and expiration date were requested but were not provided. A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. Based on the provided information, a general reagent issue was excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02604 |
| MDR Report Key | 7029094 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-14 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-10-26 |
| 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 |
| 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 | 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |