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 2017-11-08 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[92605268]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92605269]
The customer stated that they received erroneous results for four patient samples tested for li lithium (li) on a cobas 6000 c (501) module - c501. The initial high results were reported outside of the laboratory. The lower repeat results were believed to be correct. Refer to the attachment for all patient data. No adverse events were alleged to have occurred with the patients. The li reagent lot number was 194526, with an expiration date of 31-aug-2018. The field service engineer found a kink in the wash line. He adjusted the gear pump pressure and fill volume of the rinse mechanism. An additional wash step was installed on the analyzer. The customer has not reported any further issues after these actions. Upon review of calibration data, calibration signals are consistent across different lot numbers and within calibrations performed on the same reagent pack. Quality controls were within range on the day of the event and from (b)(6) 2017. Based on calibration and control data, a reagent issue could be excluded. The root cause is most likely related to sample quality. Clots /fibrin on the sample probe may lead to carry over of sample material. Based on the reaction kinetics, the pattern may indicate an issue with the water bath or the mixer, but this is not likely the cause of the event. The kinked tubing found by the field service engineer can decrease acid wash functionality and may explain the observed issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02554 |
| MDR Report Key | 7008834 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-10-19 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| 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 | NDW |
| Date Received | 2017-11-08 |
| Model Number | C501 |
| 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 | 2017-11-08 |