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 2017-04-21 for COBAS E 411 IMMUNOASSAY ANALYZER E411 RACK manufactured by Roche Diagnostics.
[73558448]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73558449]
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). It was asked, but it is not known if the erroneous result was reported outside of the laboratory. The sample initially resulted as 5 pg/ml. The customer was suspicious of the result since the last result of the patient was 300 pg/ml. The sample was then repeated, resulting as 200 pg/ml. No adverse events were alleged to have occurred with the patient. The probnp reagent lot number was provided as 16892, but this is not a correct lot number. The reagent expiration date was asked for, but not provided. The field service engineer checked the analyzer and no issues were found. 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 for this event may be sample quality, bubbles/foam on reagent surfaces, and insufficient maintenance. Preanalytical issues are the typical root cause for this type of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00847 |
| MDR Report Key | 6511596 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-21 |
| Date of Report | 2017-04-21 |
| Date of Event | 2017-03-29 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-21 |
| 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 | 2017-04-21 |
| 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 | 2017-04-21 |
| 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 | 2017-04-21 |