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 2017-03-17 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[70186850]
(b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[70186851]
The customer obtained questionable results for one patient sample using the ca2 calcium gen. 2 (ca2) reagent on a cobas 6000 c (501) module. Since (b)(6) 2017, the customer stated that they have obtained questionable calcium results for many patients; however, the laboratory does not maintain historical records of results. The customer was able to provide one example of questionable results. On (b)(6) 2017, the initial result was 7. 72 mg/dl. The result was reported outside of the laboratory to the physician. The sample was repeated with a result of 9. 51 mg/dl. The patient was not adversely affected. The ca2 lot number is 17896301 with an expiration date of 11/30/2017. Calibration and qc were acceptable prior to the event. Alarm trace information was acceptable. Annual maintenance is up-to-date, the gear pump was changed less than a year ago, and the instrument has been decontaminated. The customer is cleaning the system with the wash rack, as recommended. Water quality was acceptable for the required ph and conductibility. The customer does not have issues with any other assays. The customer performed precision checks which were acceptable. The field service representative checked the sample and reagent probes, washing station, and sample and reagent needles and did not detect any issues. He changed the sample probe and the washing station nozzle tips.
Patient Sequence No: 1, Text Type: D, B5
[71606900]
The field service representative was dispatched to the customer a second time. He checked and replaced the rinse tubing. The customer reported no further issues. Based upon this information, the issue was hardware related and resolved by the service actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00575 |
| MDR Report Key | 6412599 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-30 |
| Date of Event | 2017-03-02 |
| Date Mfgr Received | 2017-02-28 |
| Date Added to Maude | 2017-03-17 |
| 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 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CIA |
| Date Received | 2017-03-17 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-17 |
| Model Number | C501 |
| Catalog Number | 04745914001 |
| 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 | 2017-03-17 |