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 2017-08-14 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK manufactured by Roche Diagnostics.
[83311861]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83311862]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys probnp ii immunoassay (probnp) on a cobas e 411 immunoassay analyzer (e411). No erroneous results were reported outside of the laboratory. The sample was initially tested in a sample cup on top of the primary tube and resulted as approximately 300 pg/ml. The primary tube was repeated, resulting as 3600 pg/ml. No adverse events were alleged to have occurred with the patient. The probnp reagent lot number and expiration date were asked for, but not provided. The sample cup that was used in the initial measurement was not within specifications. It was also suspected that there was inadequate sample volume in the cup. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. Possible root causes may be related to the sample cup not being within specifications and/or inadequate sample volume.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01685 |
| MDR Report Key | 6792576 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-14 |
| Date of Report | 2017-08-14 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-07-24 |
| Date Added to Maude | 2017-08-14 |
| 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 |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | NBC |
| Date Received | 2017-08-14 |
| Model Number | E411 RACK |
| 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 E 411 IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-14 |
| Model Number | E411 RACK |
| 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 | 2017-08-14 |