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 2016-03-25 for COBAS E411 RACK SYSTEM 04775201001 manufactured by Roche Diagnostics.
[41268029]
This event occurred in (b)(6). (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[41268030]
The customer stated that they received erroneous results for three samples from the same patient tested for igm antibodies to cytomegalovirus (cmv igm) on an e411 analyzer. The first sample resulted as 0. 247 coi ((b)(6)) when tested on the e411 analyzer. The sample was repeated on an immulite analyzer, resulting as 1. 92 coi ((b)(6)). The sample was also repeated on a vidas analyzer, resulting as 1. 6 coi ((b)(6)). The customer released the result as (b)(6) because the immulite had generated a low (b)(6) cmv igm result, a (b)(6) cmv igg result, and the e411 generated a (b)(6) cmv igm result. The second sample resulted as 0. 635 coi ((b)(6)) when tested on the e411 analyzer on (b)(6) 2016. The sample was repeated on the immulite analyzer on (b)(6) 2016, resulting as 4. 8 coi ((b)(6)). The sample was also repeated on the vidas analyzer on (b)(6) 2016, resulting as 1. 6 coi ((b)(6)). The sample was repeated on the e411 analyzer on (b)(6) 2016, resulting as 0. 618 coi ((b)(6)). A (b)(6) result was reported outside of the laboratory since the immulite had a higher (b)(6) cmv igm result and the immulite cmv igg was also (b)(6). The (b)(6) e411 cmv igm result was also reported outside of the laboratory. The third sample resulted as 0. 556 coi ((b)(6)) when tested on the e411 analyzer on (b)(6) 2016. The sample was repeated on the immulite analyzer on (b)(6) 2016, resulting as 4. 70 coi ((b)(6)). Both results were reported outside of the laboratory. The patient was not adversely affected. The cmv igm reagent lot number was 187017. The reagent expiration date was asked for, but not provided. The service engineer ran performance testing on the analyzer, but it was not acceptable. He adjusted the measuring cell of the analyzer and then repeated performance testing.
Patient Sequence No: 1, Text Type: D, B5
[42867331]
It was clarified that when the service engineer adjusted the measuring cell, he was actually performing an adjustment of the photomultiplier tube high voltage. Performance testing was within specifications after this adjustment was performed. The customer has not had any further issues since the actions were performed by the engineer.
Patient Sequence No: 1, Text Type: N, H10
[48203174]
Samples from the patient were submitted for investigation. The customer's results could be confirmed. Additional analyses with the recomline cmv igm assay showed reactive results for these samples. The recomline assay results are in line with the results obtained by the customer using the vidas and immulite cmv igm assay, but discordant to the elecsys cmv igm results. The reactive cmv igm results in three out of four of the patient? S samples from february point to a possible acute infection with cmv. Given the limited specificity of igm immunoglobulins in general, a comprehensive serological cmv status for the patient requires a follow up sample and the assessment of a cmv specific igg titer as well as the differential diagnosis for potentially cross reactive parameters. Based upon the data provided, an instrument issue was excluded. The elecsys cmv igm assay showed good performance in general.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00349 |
| MDR Report Key | 5527273 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-25 |
| Date of Report | 2016-06-21 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LIN |
| Date Received | 2016-03-25 |
| Model Number | NA |
| Catalog Number | 04775201001 |
| 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 E411 RACK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-03-25 |
| Model Number | NA |
| Catalog Number | 04775201001 |
| 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 | 2016-03-25 |