MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-26 for COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST 03542998190 manufactured by Roche Molecular Systems.
[1055865]
The customer alleged (b)(4) for a patient with the cobas ampliprep/cobas taqman hiv-1test.
Patient Sequence No: 1, Text Type: D, B5
[8259266]
Method evaluation to include sequence analysis of specimen. There is no evidence of product malfunction at this time. Reliable results are dependent upon adequate specimen collection, transport, storage and processing procedures. It is also possible that rare mutations within the highly conserved region of the viral genome covered by the test's primers and/or probe may result in the underquantitation of or failure to detect the virus. Results from the cobas ampliprep/cobas taqman hiv-1 test should be interpretted with consideration of all clinical and laboratory findings. Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next; users perform method correlation studies in their laboratory to quantify differences. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20825978]
Internal evaluation confirmed the customer allegations. Based on the sequencing results, it is likely that the cobas ampliprep/cobas taqman test underquantitated the viral load in the result under question for one patient. The procedural limitations section of the package insert contains the following applicable statements. "though rare, mutations within the highly conserved region of the viral genome covered by the cobas ampliprep/cobas taqman test primers and/or probe may result in the underquantitation of or failure to detect the virus. " "due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform correlation studies in their laboratory to quantify technology differences. " the cobas ampliprep/cobas taqman test is intended to be used as a monitoring assay and as such, it is unlikely that a physician would change a patient's treatment based on a single data point. A patient's history and clinical manifestations would be considered before changes to treatment were made. It is concluded there was no likely risk to the patient and would not result in serious injury or death in this case. A second generation of the test has been developed that includes amplification and detection of a second region (the ltr region in addition to the gag gene of the viral genome) which will reduce incidents of underquantitation of or failure to detect the virus due to mutations. Submission of a supplement pma is anticipated for mid 2009.
Patient Sequence No: 1, Text Type: N, H10
[20835853]
The customer alleged underquantitated results for a patient with the cobas ampliprep/cobas taqman test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2009-00006 |
| MDR Report Key | 1351264 |
| Report Source | 06 |
| Date Received | 2009-03-26 |
| Date of Report | 2009-05-08 |
| Date of Event | 2008-04-08 |
| Date Mfgr Received | 2009-03-03 |
| Date Added to Maude | 2010-03-03 |
| 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 | 0 |
| Manufacturer Contact | MR. ROBERT PIGOZZI |
| Manufacturer Street | 4300 HACIENDA DRIVE |
| Manufacturer City | PLEASANTON CA 945880900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945880900 |
| Manufacturer Phone | 9257308272 |
| Manufacturer G1 | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Street | 1080 US HWY 202 |
| Manufacturer City | SOMERVILLE NJ 08876377 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08876 3771 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS AMPLIPREP/COBAS TAQMAN HIV-1 TEST |
| Generic Name | MONITOR TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2009-03-26 |
| Catalog Number | 03542998190 |
| Lot Number | K04584 |
| Device Expiration Date | 2009-03-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 08876377 US 08876 3771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-26 |