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 2015-11-05 for COBAS 8000 C502 MODULE 05964067001 manufactured by Roche Diagnostics.
[30461618]
Patient Sequence No: 1, Text Type: N, H10
[30461619]
The customer reported that they received questionable results for one patient sample tested for tina-quant igm gen. 2 (igm) and a second patient sample tested for tina-quant iga gen. 2 (iga). The customer was unable to provide any further information for the sample tested for iga. It was determined that the sample tested for igm had erroneous results. The customer stated that all other patients tested for igm had results greater than 1000 and these results were not questioned. The customer also mentioned that they had failed a proficiency survey in june for igm and iga. The patient sample initially resulted as 1207 mg/dl accompanied by a data flag. The sample was then automatically diluted by the analyzer, resulting as 3408 mg/dl. The 3408 mg/dl value was reported outside of the laboratory. The customer thinks that the result was questioned by the doctor and this is why it was repeated. The sample was repeated on a c502 analyzer with an automatic dilution, but the customer did not know if it was the same analyzer. The repeat result was 885 mg/dl and this value was believed to be correct. Other samples collected from the patient in question were repeated and all had results < 1000. No specific results were provided. The patient was not adversely affected. The igm reagent lot number was 61403601, with an expiration date of 02/28/2017. The field service representative could not determine a cause for the issue. He ran a precision check on the analyzer and results were within specification. The customer ran calibration and controls; results were within specified limits.
Patient Sequence No: 1, Text Type: D, B5
[33617115]
The field service representative changed probes on the analyzer and checked for usage of tube adapters. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was asked for, but not provided. The customer has not had any further problems since the issue occurred. Based upon the information provided, the most likely cause of the event was an issue unique to the patient sample, such as interference, or a hardware issue that was resolved by the field service activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04443 |
| MDR Report Key | 5203895 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-05 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-10-06 |
| Date Mfgr Received | 2015-10-14 |
| Date Added to Maude | 2015-11-05 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CFQ |
| Date Received | 2015-11-05 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| 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 46250 US 46250 |
| Brand Name | COBAS 8000 C502 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-05 |
| Model Number | NA |
| Catalog Number | 05964067001 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-05 |