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 2017-03-01 for COBAS 6000 C (501) MODULE C501 manufactured by Roche Diagnostics.
[68781419]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68781420]
The customer complained of an erroneous high result for 1 patient tested for lipc lipase colorimetric assay (lipc). It is not known if the erroneous result was reported outside of the laboratory. The initial lipc result from a cobas 6000 c (501) module was 129. 1 u/l. This result was an aliquot sample from the customer? S modular pre-analytic (mpa) system. Since all other patient test results were normal, the sample from the primary tube was repeated on (b)(6) 2017 and the result was 21. 0 u/l. To confirm this, a secondary tube that had been drawn at the same time as the primary tube was repeated twice on the c501 module and the results were 19. 7 u/l and 25. 0 u/l. No adverse event occurred. The lipc reagent lot number was 179823 with an expiration date of 09/30/2017. The customer stated that this issue was only observed for this one patient.
Patient Sequence No: 1, Text Type: D, B5
[117873543]
Calibration and quality control (qc) data were acceptable. The discrepant lipc results were from the same analyzer and only for 1 patient. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Since calibration and qc data were acceptable and since the issue occurred only once, both a general reagent issue and hardware issue have been excluded. Since the assumed correct result was confirmed by repeating the sample from the primary tube and by repeating a sample from a secondary tube drawn at the same time as the primary tube twice, the most likely root cause is a preanalytical issue. Either too much sample was transferred via the sample probe (through deposits on the outside) or debris caused an artificial signal, however, since the reaction monitors are no longer available, this cannot be verified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00436 |
| MDR Report Key | 6368695 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-01 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-01-30 |
| Date Mfgr Received | 2017-02-06 |
| Date Added to Maude | 2017-03-01 |
| 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 | CHI |
| Date Received | 2017-03-01 |
| 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 |
| Brand Name | COBAS 6000 C (501) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-01 |
| 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 | 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 | 2017-03-01 |