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 2017-06-21 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[78351954]
Unique (b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[78351955]
The customer obtained questionable test results on one patient sample using the crphs cardiac c-reactive protein (latex) high sensitive assay (crp-hs) on the cobas 8000 c 502 module when performing a precision test. The customer stated that some results were released outside the laboratory to the physician; however, the customer was unable to specify which results were released. All results are in units of mg/l. The crp-hs results were 1. 32, 1. 40, 1. 43, 1. 02, and 1. 75. The known concentration of the patient sample was 1. 20. There was no allegation that any action was taken based upon the released results, nor that an adverse event occurred. The crp-hs reagent lot number is 138613; the expiration date was not provided. The customer was using a modular crp-hs reagent (designed for the roche modular p system) on a development channel on the roche c502 analyzer at the time of the results. The customer stated that quality control (qc) results with the core system crp-hs reagent are typically acceptable. However, when using the modular crp-hs reagent on a development channel in parallel with other modular reagents, the qc and patient results are varied. In the customer's laboratory, they use the modular crp-hs reagent for patient results. The field service representative found a dripping rinse nozzle. He exchanged the solenoid valves and confirmed that the module met specification. The specific root cause for this issue was the dripping rise nozzle. The issue was resolved by the service activities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01297 |
| MDR Report Key | 6658080 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-21 |
| Date of Report | 2017-06-21 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-06-21 |
| 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 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NQD |
| Date Received | 2017-06-21 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| 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 |
| Brand Name | COBAS 8000 C 502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-06-21 |
| Model Number | C502 |
| Catalog Number | 05964067001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2017-06-21 |