MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-03 for COBAS E411 DISK SYSTEM 04775279001 manufactured by Roche Diagnostics.
[2229756]
The user received questionable intact human chorionic gonadotropin + the ss-subunit (hcg+ss) results for one patient serum sample. The initial result was >10,000 miu/ml with a data flag. They repeated the sample with a 1:100 dilution and the result was 21. 19 miu/ml with a data flag. They again repeated the sample with a 1:100 dilution with a result of 55289 miu/ml with a data flag. Only the result of 55289 miu/ml was reported outside the laboratory. There was no resulting treatment or adverse effect to the patient due to the erroneous result. The hcg+ss reagent lot number was 16250103. The field service representative checked the instrument and could not find a cause. To verify the analyzer operation, he ran performance testing and the user ran a precision check. All tests passed.
Patient Sequence No: 1, Text Type: D, B5
[9376905]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[9635131]
The investigation could not determine a specific root cause. An analyzer issue was not evident as performance testing was within specification. A reagent issue was not evident as calibration and quality control were acceptable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05974 |
| MDR Report Key | 2322876 |
| Report Source | 05,06 |
| Date Received | 2011-11-03 |
| Date of Report | 2012-02-16 |
| Date of Event | 2011-10-11 |
| Date Mfgr Received | 2011-10-14 |
| Date Added to Maude | 2011-11-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| 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 E411 DISK SYSTEM |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LCX |
| Date Received | 2011-11-03 |
| Model Number | NA |
| Catalog Number | 04775279001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-11-03 |