MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-11-30 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[61204057]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[61204058]
The customer received questionable low elecsys cmv igg assay results for one patient. On (b)(6) 2016, the initial result from an aliquot produced by the modular preanalytic analyzer (mpa) was < 0. 150u/ml with a data flag (non-reactive). On (b)(6) 2016, the result from the primary sample tube was 56. 25 u/ml (reactive). On (b)(6) 2016, both samples were repeated. The result from the aliquot was < 0. 150u/ml with a data flag (non-reactive) and the result from the primary sample tube was 51. 59 u/ml (reactive). The erroneous results were reported outside the laboratory. The result of 50 u/ml was confirmed in another laboratory with another sample from the patient. Therefore, the customer believed the higher result to be correct. The patient was not adversely affected. The reagent lot number was 174473 with an expiration date of september 2017. The customer suspected there was contamination as the nurse had stated there was a problem with this sample.
Patient Sequence No: 1, Text Type: D, B5
[63651818]
A specific root cause could not be determined. Additional information for further investigation was requested but was not provided. Based on the provided data, a general reagent issue could most likely be excluded. Quality control data were within specifications. The most likely root causes include issues with sample quality, low sample volume, or possible mismatch of samples.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01867 |
| MDR Report Key | 6134874 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-11-30 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-11-10 |
| Date Mfgr Received | 2016-11-15 |
| Date Added to Maude | 2016-11-30 |
| 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 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LKQ |
| Date Received | 2016-11-30 |
| 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 | 2016-11-30 |
| 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 | 2016-11-30 |