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 2017-06-16 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE manufactured by Roche Diagnostics.
[77875414]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[77875415]
The customer received questionable elecsys vitamin b12 immunoassay and folate results. The customer had experienced qc imprecision and tested the patient samples in duplicate. No data was provided for the folate issue. Of the vitamin b12 data provided for 70 patient samples, only the results for six were discrepant. Information concerning if any of the results were reported outside the laboratory was requested, but it was unknown. There was no allegation of an adverse event. The vitamin b12 reagent lot number was 23140100. The expiration date was requested but was not provided. The customer only runs this module twice a week. In between, the customer tests clinical trial samples if they are available. If not available, the system is shut down. The customer did not centrifuge the samples after they were thawed and vortexed. The customer was also not using the sample tube adapters recommended for use with 13x75 mm tubes. The field service representative checked the analyzer and found no issues. A precision check was performed.
Patient Sequence No: 1, Text Type: D, B5
[118339247]
The field service representative found that the prewash station adjustment was not acceptable and corrected it by adjusting the prewash magnets. He ran analyzer performance testing. Upon follow up, the customer confirmed there were no further issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01260 |
| MDR Report Key | 6647766 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-16 |
| Date of Report | 2017-07-07 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-06-16 |
| 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 | 2017-06-16 |
| 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 | 2017-06-16 |
| 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 | 2017-06-16 |