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 2017-06-02 for COBAS 8000 C 702 MODULE C702 06473245001 manufactured by Roche Diagnostics.
[76662630]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[76662631]
The customer complained of erroneous results for 1 patient tested for hdlc3 hdl-cholesterol plus 3rd generation (hdlc3) on a cobas 8000 c 702 module. The initial hdlc3 result from the primary tube was 0 mg/dl. The sample was repeated the same day from the same primary tube using a different reagent cassette with the same lot number and the result was 48 mg/dl. It is not clear which result was considered to be correct or if erroneous results were reported outside of the laboratory. This information was requested but has not been provided. There was no allegation that an adverse event occurred. The hdlc3 reagent lot number was 156809 with an expiration date of 03/31/2018. The customer? S calibration and quality controls (qc) results were comparable to those from other dates. Nothing abnormal was observed. Measuring cells and lamps were last replaced on (b)(6) 2017. Weekly maintenance was last performed on (b)(6) 2017. A specific root cause was not identified. Additional information was requested for investigation but was not provided.
Patient Sequence No: 1, Text Type: D, B5
[79043113]
It was clarified that the result of 0 mg/dl was not believed to be correct and was not reported outside of the laboratory. The result of 48 mg/dl was believed to be correct and was reported outside of the laboratory. A field service engineer decontaminated and adjusted the sample and reagent probes. After these actions, no discrepant results were observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2017-01134 |
| MDR Report Key | 6608266 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-02 |
| Date of Report | 2017-06-05 |
| Date of Event | 2017-05-09 |
| Date Mfgr Received | 2017-05-10 |
| Date Added to Maude | 2017-06-02 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LBS |
| Date Received | 2017-06-02 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 8000 C 702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-02 |
| Model Number | C702 |
| Catalog Number | 06473245001 |
| 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 | 2017-06-02 |