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 2015-11-18 for COBAS 8000 C702 MODULE 06473245001 manufactured by Roche Diagnostics.
[31570713]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[31570714]
The customer complained of erroneous results for 1 patient sample tested for rheumatoid factors ii (rf-ii). The date of event was not provided. The initial result was 6 iu/ml with a data flag. The sample was repeated and the result was 0 iu/ml. The sample was repeated again using a 1:3 dilution and the result was 21 iu/ml. The result of 21 iu/ml was reported outside of the laboratory. It is not known which result was believed to be correct. The patient was not adversely affected. The rf-ii reagent lot number and expiration date were not provided.
Patient Sequence No: 1, Text Type: D, B5
[32492546]
Upon further investigation, the data flag >kin associated with the result of 6 iu/ml means that the prozone check limit exceeds the specified limit. This is caused by the sample concentration being too high. High sample concentration or interferences can also cause unflagged results of zero. When a >kin flag displays the customer is advised to dilute and repeat the sample which is what the customer did. It was noted that the result of 21 iu/ml was believed to be the correct result. Calibration and quality controls were acceptable. A problem with the reagent or instrument is not likely. The most likely root cause of the erroneous low results is an unknown interference.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04588 |
| MDR Report Key | 5234496 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-18 |
| Date of Report | 2015-12-02 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2015-10-28 |
| Date Added to Maude | 2015-11-18 |
| 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 C702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DHR |
| Date Received | 2015-11-18 |
| Model Number | NA |
| 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 46250 US 46250 |
| Brand Name | COBAS 8000 C702 MODULE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2015-11-18 |
| Model Number | NA |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-18 |