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 2017-09-15 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[86416929]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86416930]
The customer stated that they received erroneous results for one patient sample tested for dig digoxin (dig) on a cobas 6000 c (501) module - c501. No erroneous results were reported outside of the laboratory. The sample initially resulted as 1. 17 ng/ml. The sample was repeated, resulting as 0. 97 ng/ml. The sample was repeated three more times on (b)(6) 2017, resulting as 1. 44 ng/ml, 1. 25 ng/ml, and 1. 03 ng/ml. No adverse events were alleged to have occurred with the patient. It was recommended to the customer to collect another sample from the patient. The dig reagent lot number was 227984. The reagent expiration date was asked for, but not provided. The customer performed precision studies with another patient sample. Quality control recovery was stated to be "not so good".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02003 |
| MDR Report Key | 6868799 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-15 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-08-25 |
| Date Mfgr Received | 2017-08-28 |
| Date Added to Maude | 2017-09-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | KXT |
| Date Received | 2017-09-15 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-09-15 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 | 2017-09-15 |