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 2017-09-29 for COBAS 8000 E 602 MODULE E602 05990378001 manufactured by Roche Diagnostics.
[87765430]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[87765431]
The customer stated that they received an erroneous result for one patient sample tested for elecsys ferritin (ferr) on a cobas 8000 e 602 module (e602). The sample initially resulted as 1952 ng/ml and this value was reported outside of the laboratory to the physician. The physician questioned the result, so the sample was repeated. The sample was diluted times 400 and repeated, resulting as 794873 ng/ml. The repeat result was believed to be correct. The patient was not adversely affected. The ferr reagent lot number was 192154. The reagent expiration date was asked for, but not provided. The field service engineer determined that the pinch tubing was possibly worn. He changed syringe seals and pinch tubing. He performed a complete decontamination of the analyzer and performed preventive maintenance. He ran precision studies. The customer ran controls and results were within their specified ranges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02143 |
| MDR Report Key | 6903367 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-29 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-04 |
| Date Mfgr Received | 2017-09-12 |
| Date Added to Maude | 2017-09-29 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 2017-09-29 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 8000 E 602 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-29 |
| Model Number | E602 |
| Catalog Number | 05990378001 |
| 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 | 2017-09-29 |