MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-01 for COBAS AMPLIPREP/COBAS TAGMAN CMV TEST 04902025190 04092025150 manufactured by Roche Diagnostics.
[5946051]
Unable to verify reportable range during laboratory performance verification. Unable to verify limit of detection as stated in product insert. Contacted manufacturer who states that device does not use limit of detection as indicated in the product insert for reporting positive vs. Negative for test target. This practice contradicts with clia regulatory standards for reporting positive results using established limit of detection ((b)(4), reference on fda site as guidance document for product development). Clinical reporting should be safe guarded by having minimum of 95 percent confidence for positive results and/or accompanied by the disclaimer for limit of detection for the test (reference attached). Conclusions: test does not perform as expected if having lod 91 iu/ml. Manufacturer's package insert specifies limit of detection as 91 iu/ml thus expected performance for values below 91 iu/ml would be to observe reportable result as target not detected or employment of the disclaimer that specifies that results below the lod are reported as positive and should be taken with discretion since they are less than 95 percent confident. Limit of quantitation (loq) is different parameter of the test and only values below loq but above lod should be reported as positively detected. During performance verification we observed 75 samples with expected results "target not detected" reported as "positive. " we believe that device possesses serious risk of reporting false-positive result without any justifiable clinical significance thus projecting unnecessary financial and health burden for patients targeted for treatment of omv viremia based on "detected"/ "not detected" algorithm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042997 |
| MDR Report Key | 4834762 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-06-01 |
| Date Added to Maude | 2015-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAGMAN CMV TEST |
| Generic Name | COBAS AMPLIPREP/COBAS TAGMAN CMV TEST |
| Product Code | PAB |
| Date Received | 2015-06-01 |
| Model Number | 04902025190 |
| Catalog Number | 04092025150 |
| Lot Number | T07375 |
| ID Number | 00875197002584 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | COBAS AMPLIPREP/COBAS TAGMAN CMV TEST |
| Generic Name | COBAS AMPLIPREP/COBAS TAGMAN CMV TEST |
| Product Code | PAB |
| Date Received | 2015-06-01 |
| Model Number | 04902025190 |
| Catalog Number | 04092025190 |
| Lot Number | T05709 |
| Device Expiration Date | 2015-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | COBAS AMPLIPREP/COBAS TAGMAN WASH REAGENT |
| Generic Name | COBAS AMPLIPREP/COBAS TAGMAN WASH REAGENT |
| Product Code | LDT |
| Date Received | 2015-06-01 |
| Model Number | 03587797190 |
| Catalog Number | 03587797190 |
| Lot Number | T15439 |
| Device Expiration Date | 2017-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | AMPLIPREP |
| Generic Name | AMPLIPREP |
| Product Code | JJH |
| Date Received | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MODULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY. 202 SOUTH BRANCHBURY NJ 08876 US 08876 |
| Brand Name | AMPLIPREP |
| Generic Name | AMPLIPREP |
| Product Code | JJH |
| Date Received | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOUTH BRANCHBURY NJ 08876 US 08876 |
| Brand Name | AMPLIPREP |
| Generic Name | AMPLIPREP |
| Product Code | JJH |
| Date Received | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOUTH BRANCHBURY NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-01 |