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 2015-12-15 for COBAS 6000 E601 MODULE 04745922001 manufactured by Roche Diagnostics.
[33474501]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33474502]
The customer reported that they received erroneous results for one patient sample tested for igg antibodies to cytomegalovirus (cmv igg). The sample initially as 3 u/ml, which is considered a positive result. To confirm the result, the sample was repeated on (b)(6) 2015, resulting as 17. 63 u/ml. The 17. 63 u/ml value is considered a positive result and was reported outside of the laboratory. Since the patient is a pregnant woman and previous measurements of the patient were negative for cmv igg, the 17. 63 u/ml value was complained. On (b)(6) 2015 a new sample was collected from the patient and tested. The new sample resulted as 0. 150 u/ml accompanied by a data flag, which is considered non-reactive. The new sample result of 0. 150 u/ml accompanied by a data flag was reported outside of the laboratory and considered to be correct. The patient was not adversely affected. The cmv igg reagent lot number was 185518. The reagent expiration date was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[35781204]
A specific root cause could not be determined based on the provided information. The affected sample was not available for further investigation. Based on the evaluated data, the performance of the (b)(6) test is ok.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-06027 |
| MDR Report Key | 5297095 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-15 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-11-07 |
| Date Mfgr Received | 2015-11-27 |
| Date Added to Maude | 2015-12-15 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LIN |
| Date Received | 2015-12-15 |
| 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 E601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-12-15 |
| 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 | 2015-12-15 |