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 2017-09-14 for COBAS E 411 IMMUNOASSAY ANALYZER E411 DISK 4775279001 manufactured by Roche Diagnostics.
[87222379]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[87222380]
The customer received questionable low elecsys probnp ii immunoassay results for several patients. The customer was alerted to the issue by a comparison study with a non-roche point of care (poc) instrument in their clinic. After testing on the poc instrument, they would take additional sample and test it on the cobas e 411 immunoassay analyzer. Two general examples were provided as a result from the poc device in the clinic of approximately 900-1000 pg/ml and results of 14 pg/ml and 34 pg/ml from the cobas e411. As these results did not match the poc device, they repeated the samples on the cobas e411 and the results were 724 pg/ml and 1800 pg/ml. Specific data was provided for three patients. Patient 1 result from the poc device on (b)(6) 2017 was 1090 pg/ml. On (b)(6) 2017, the result from the cobas e411 was 32 pg/ml. Due to the discrepancy, the same sample was repeated on the poc device and the result was 975 pg/ml. Patient 2 result from the poc device on (b)(6) 2017 was 1390 pg/ml. The same sample was tested on the cobas e411 with a result of 16. 94 pg/ml. Patient 3 was a female. The result from the cobas e411 on (b)(6) 2017 was 14. 54 pg/ml which was considered erroneous given she has heart failure. The repeat result from the cobas e411 using the same sample was 743. 4 pg/ml and was believed to be correct. No poc device result was provided for this patient. Information concerning if any erroneous result was reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. The reagent lot number was 209223. The expiration date was requested but was not provided. Review of the provided qc data found results were within ranges. However, precision issues were noted. The analyzer alarm trace contained multiple errors related to insufficient sample volume or a clot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01986 |
| MDR Report Key | 6865131 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-14 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-25 |
| Date Added to Maude | 2017-09-14 |
| 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 | 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NBC |
| Date Received | 2017-09-14 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-14 |
| Model Number | E411 DISK |
| Catalog Number | 4775279001 |
| 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 | 2017-09-14 |