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 2017-10-26 for COBAS 8000 E 602 MODULE E602 manufactured by Roche Diagnostics.
[91100978]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91100979]
The customer complained of erroneous results for 1 patient sample tested for elecsys ferritin (ferritin) on two cobas 8000 e 602 modules. This medwatch will cover e 602 module with serial number (b)(4) (module b). Refer to medwatch with (b)(6) for information on e602 module with serial number (b)(4) (module a). The initial ferritin result from e602 with serial number (b)(4) (module b) was 3. 6 ng/ml. The sample was repeated on e602 with (b)(4) (module a) and the result was 2. 6 ng/ml. The result of 2. 6 ng/ml was reported outside of the laboratory where it was questioned by the patient. On (b)(6) 2017 the sample was repeated on 2 additional e602 modules (module c and module d). The repeat result from e602 module c was 513. 1 ng/ml. The repeat result from e602 module d was 543. 6 ng/ml. The result of 543. 6 ng/ml was believed to be correct. There was no allegation that an adverse event occurred. The ferritin reagent lot number was 192154. The expiration date was not provided. On the day of the event there were several instrument alarms related to abnormal sample probe movement and abnormal sample aspiration on e602 with serial number (b)(4) (module b) and e602 with (b)(4) (module a).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02427 |
| MDR Report Key | 6979854 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-26 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-08-30 |
| Date Mfgr Received | 2017-10-05 |
| Date Added to Maude | 2017-10-26 |
| 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 | 0 |
| 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 | 2017-10-26 |
| Model Number | E602 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-26 |