MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-07 for AMPLICOR HIV-1 MONITOR TEST, V1.5 2118560018 manufactured by Roche Molecular Systems.
[770748]
The customer is the doctor of a patient who received results from laboratories for a patient and is questioning the negative result. Initially, a specimen from a patient, generated negative results with the amplicor monitor test. Eighteen months later, the same patient returned with symptoms and at the time the doctor requested a repeat of the test. Subsequent to the second testing the individual expired.
Patient Sequence No: 1, Text Type: D, B5
[8010369]
The lab is using the amplicor monitor test as a screening assay which is off label from the monitoring indications for use in the package insert. An investigation is in progress to get more details regarding the incident.
Patient Sequence No: 1, Text Type: N, H10
[21474698]
New information received from the testing center indicates that the test was performed as requested by the ordering physician, and was performed according to product package insert instructions. There are two test codes offered by the testing center that use the amplicor hiv-1 monitor test. One of these test codes 10103 uses the test in a qualitative manner. It was stated that the test performed on this patient was the one that was requested, not 10103, and was performed on-label. According to the customer, the lab report listed the results as "less that 50 cp/ml" and the patient's test results were interpreted to be "negative" for hiv-1. The customer stated that she was surprised to receive a quantitative result when a qualitative result was expected. Although the communication indicated that the result was "less that 50 cp/ml" and hiv-1 "negative", there was no raw data provided and the interpretation of whether hiv-1 was detected could not be determined. Without knowing the absorbance value generated, it is unknown if hiv-1 rna was detected or not. Multiple attempts were made to obtain this information but they were unsuccessful. Review of the amplicor hiv-1 monitor package insert shows: "reliable results are dependent on appropriate specimen collection, transport, storage and processing procedures". No information was provided on how the sample was collected, shipped and stored prior to testing. "results from the amplicor hiv-1 monitor test, v1. 5 should be interpreted with consideration of all clincial and laboratory findings". There is no indication that serology or other assays were performed at the time of initial testing with the amplicor hiv-1 monitor test, v1. 5. "the test is not intended to be used as a screening test for hiv-1 or as a diagnostic test to confirm the presence of hiv-1 infection". The statement received from the customer indicates that qualitative results were expected and perhaps the wrong test was ordered. Kit batch and specimen not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2007-00006 |
| MDR Report Key | 960361 |
| Report Source | 05 |
| Date Received | 2007-12-07 |
| Date of Event | 2006-02-04 |
| Date Mfgr Received | 2007-11-07 |
| Date Added to Maude | 2008-12-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICOR HIV-1 MONITOR TEST, V1.5 |
| Generic Name | MONITOR TEST, HIV-1 |
| Product Code | MTL |
| Date Received | 2007-12-07 |
| Catalog Number | 2118560018 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 967560 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HWY 202 SOMERVILLE NJ 088763771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-07 |