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 2017-11-16 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.
[93355865]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[93355866]
The customer complained of erroneous results for 1 patient sample tested for elecsys free psa immunoassay (free psa) on 3 cobas 8000 e 602 modules. Results were not reported outside of the laboratory. It is not known which results were believed to be correct. This medwatch will cover e602 module serial (b)(4). The initial free psa result on e602 module with serial number (b)(4) was 0. 011 ng/ml. The sample was repeated on e602 module serial number (b)(4) and the result was 0. 671 ng/ml. The sample was repeated on e602 module serial number (b)(4) and the result was 0. 787 ng/ml. Based on the data provided, there is an additional patient sample with erroneous free psa results. It is not clear whether this additional sample is from the 1 patient the customer complained about or if this is for a different patient. It is also not known which e602 module produced the results. Clarification on this has been requested but has not been provided. The initial free psa result was 0. 01 ng/ml. The repeat result was 0. 395 ng/ml. It is not known which result is believed to be correct. This information was requested but has not been provided. There was no allegation that an adverse event occurred. The free psa reagent lot number and expiration date were not provided. A specific root cause was not identified. Additional information was requested for investigation but was not provided. The customer has not provided any additional information related to this event, therefore the investigation could not be completed. A general product problem is excluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02634 |
| MDR Report Key | 7037790 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-16 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-10-26 |
| Date Added to Maude | 2017-11-16 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2017-11-16 |
| Model Number | E602 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-11-16 |
| Model Number | E602 |
| 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 | 2017-11-16 |