MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-12 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE 03739040692 manufactured by Roche Diagnostics.
[86844220]
Patient Sequence No: 1, Text Type: N, H10
[86844221]
The customer stated that they received multiple low results for elecsys vitamin b12 immunoassay on (b)(6) 2017. These low results were not initially discovered until (b)(6) 2017. The data for 73 samples was provided. Of the data provided, 15 samples had the original tubes repeated as the technician noticed values of <30 pg/ml were being obtained. Of the 15 samples repeated, 3 results were a reportable malfunction. For sample 1 the initial vitamin b12 result was 33 pg/ml with a repeat result of 340 pg/ml. For sample 2 the initial vitamin b12 result was 37 pg/ml with a repeat result of 259 pg/ml. For sample 3 the initial vitamin b12 result was 32 pg/ml with a repeat result of 391 pg/ml. The repeat results were deemed to be correct. For the 15 samples that were repeated, their initial results were not sent outside of the laboratory. For the other 58 samples with low results, corrected reports with "unable to provide results" had to be sent out. There were no adverse events. The vitamin b12 reagent lot is 21015502 with an expiration date of 30-sep-2018. The customer stated that the problem has not occurred since the original date of event. Qc was performed later in the evening of (b)(6) 2017 and the data was acceptable. The customer believes the reagent pack might have been mishandled, but since the event was not discovered until a later date the reagent pack was exhausted and patient samples had been discarded. The field engineering specialist performed a performance check which failed. He also noted that the photomultiplier tube high voltage (pmt hv) was too high. He replaced the measuring cell as it was due for replacement soon, and he adjusted the pmt hv. He performed assay performance checks and mechanism checks which all passed. The customer performed calibration and qc which all passed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01954 |
| MDR Report Key | 6857513 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-12 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-08-09 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-09-12 |
| 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 | 2017-09-12 |
| Model Number | E MODULE |
| Catalog Number | 03739040692 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-09-12 |
| Model Number | E MODULE |
| Catalog Number | 03739040692 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-09-12 |