MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-08 for COBAS 8000 C 502 MODULE C502 05964067001 manufactured by Roche Diagnostics.
[69330009]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[69330010]
The customer stated that they received erroneous results for one patient sample tested for igm-2 tina-quant igm gen. 2 (igm) on a cobas 8000 c 502 module (c502). An aliquot of the sample initially resulted as 1907 mg/dl accompanied by a data flag. The sample was automatically repeated by the analyzer with a dilution, resulting as 6706 mg/dl accompanied by a data flag. This result was reported outside of the laboratory and questioned by the doctor. The primary tube of the sample was pulled and repeated, resulting as 1021 mg/dl accompanied by a data flag. The customer then performed a manual 1:10 dilution of the sample and placed it back on the analyzer to repeat it. Upon repeat, the instrument performed a 1:9 dilution of the sample as programmed for the application and the raw repeat value was 84 mg/dl. The customer then ran the manually diluted sample again and it resulted with a raw value of 86 mg/dl, which calculates to a final value of 860 mg/dl when accounting for the manual dilution factor. The repeat result was believed to be correct. The patient was not adversely affected. The igm reagent lot number was 17244501, with an expiration date of 06/30/2018. The field service engineer found issues with a seal, probe, and debris. He replaced the seals and probe. He checked the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-00501 |
| MDR Report Key | 6386783 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-08 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2017-03-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CFQ |
| Date Received | 2017-03-08 |
| 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 | 2017-03-08 |
| 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 | 2017-03-08 |