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 2017-09-26 for COBAS 8000 C (701) MODULE C701 05641489001 manufactured by Roche Diagnostics.
[88243418]
Unique identifier (udi)#: (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[88243419]
The customer received a questionable low crpl3 c-reactive protein gen. 3 result for one patient sample. The initial result was 0. 39 mg/l and was reported outside the laboratory. The physician did not believe this result because the previous results for the patient were high. A sample that had been drawn at the same time as the original sample was tested and the result was 58. 89 mg/l. There was no allegation of an adverse event. The reagent lot number was 238106. The expiration date was requested but was not provided. Calibration and qc results on the day of the event were acceptable. Review of the provided reaction curves did not indicate any issues. Contamination due to misadjustment of the water pressure or probe position could be excluded. The difference between the reaction curves for the two testings indicated no sample was pipetting for the first test which generated the erroneous result. A specific root cause could not be identified, but accumulated contamination on the sample probe was suspected to be the root cause. The customer reported no further issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02084 |
| MDR Report Key | 6893040 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-26 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-09-26 |
| 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 |
| 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 (701) MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DCN |
| Date Received | 2017-09-26 |
| Model Number | C701 |
| Catalog Number | 05641489001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-09-26 |