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 2017-06-12 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[77646473]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77646474]
The customer obtained a questionable low test result for one patient sample using the elecsys ferritin assay on the cobas 8000 e 602 module (e602). The initial ferritin result was 0. 588 ng/ml. The repeat result was 3105 ng/ml. No adverse event occurred. The ferritin reagent lot number and expiration date was requested but not provided. Calibration was successful prior to the event. Customer performed a reagent probe check and the analyzer generated an abnormal reagent probe movement alarm. He believed the probe was hitting a closed reagent lid. The field service representative found the sample pipetter liquid level detector (lld) circuit was out of adjustment. He adjusted the lld, performed an instrument overview, and performed mechanism checks which passed. He conducted an assay performance check which was acceptable. The customer performed calibration and qc afterwards which passed. The instrument performed within specifications. The root cause for this event was the maladjusted sample pipetter lld circuit. This can cause an early lld signal, and therefore too little sample is pipetted. After service was performed, the analyzer worked according to specifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01212 |
| MDR Report Key | 6633183 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-05-19 |
| Date Mfgr Received | 2017-05-20 |
| Date Added to Maude | 2017-06-12 |
| 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 | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2017-06-12 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | COBAS 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-12 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2017-06-12 |