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 2017-02-02 for COBAS 6000 C (501) MODULE C501 04745914001 manufactured by Roche Diagnostics.
[66361525]
This event occurred in (b)(6). Unique identifier (udi)#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66361526]
The customer questioned results for 2 patient samples tested for crplx c-reactive protein (latex) - (crplx) on a cobas 6000 c (501) module. Based on the information provided, the results for 1 patient were erroneous and it is not known if the erroneous results for this patient were reported outside of the laboratory. The initial crplx result was 0. 51 mg/l with a data flag. On (b)(6) 2017 the sample was repeated and the result was 116. 45 mg/l. The sample was run using micro cups both times. No adverse event occurred. The crplx reagent lot number was 13848601 with an expiration date of 12/31/2017. Upon review of the reaction monitor provided by the customer, it appears that either no sample or an insufficient sample amount was pipetted at the time of the 0. 51 mg/l result with the data flag. Upon review of the alarm trace, a sample cup type error was observed on (b)(6) 2017 and an abnormal probe sucking alarm was observed on (b)(6) 2017. Based on the data provided for investigation, there may have been a problem with the sample (foam or bubbles on the surface) or a problem with the use of the micro cups. Both issues can cause erroneous low results. The use of micro cups need to be programmed in the software of the instrument. If this is not done, the sample pipetting may be inaccurate and lead to discrepant results as the sample aspiration parameters are different between micro cups and other sample types.
Patient Sequence No: 1, Text Type: D, B5
[68493298]
The customer is using micro cups that are inserted into a normal hitachi cup. The bar code label is stuck on the hitachi cup. The use of micro cups inside of a hitachi cup is out of specification for the c6000 system. Micro cups can be used directly on the rack or inserted in a 16 mm tube. The system has a height detection function. Specifications surrounding the use of cups and micro cups is addressed in the operator manual. In this case, the customer used a micro cup inside of a hitachi cup. Based on the height detection function, this was identified as a 75 mm tube and the aspiration of the sample was incorrect. The sample aspiration parameters for micro cups are different than the sample aspiration parameters for tubes or hitachi cups.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-00205 |
| MDR Report Key | 6296158 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-02 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-01-14 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-02-02 |
| 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 | DCN |
| Date Received | 2017-02-02 |
| 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 | 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 | 2017-02-02 |
| 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 | 2017-02-02 |