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 2017-03-30 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE manufactured by Roche Diagnostics.
[71215568]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[71215569]
The customer received a questionable elecsys vitamin b12 immunoassay result for one patient sample. The initial result was > 2000 pg/ml. The repeat result from a 1:2 dilution was 500 pg/ml. The customer stated the sample was repeated a third time and the result "was almost the same result" as the repeat result. No specific data was provided. 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 177486. The expiration date was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[73018000]
As no sample material was available for further investigation, a specific root cause could not be determined. Additional information for further investigation was requested but was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00671 |
| MDR Report Key | 6445488 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-30 |
| Date of Report | 2017-04-12 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-07 |
| Date Added to Maude | 2017-03-30 |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | CDD |
| Date Received | 2017-03-30 |
| Model Number | E MODULE |
| Catalog Number | ASKU |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-30 |
| Model Number | E MODULE |
| Catalog Number | ASKU |
| 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 | 2017-03-30 |