MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-06-03 for AMPLICOR HIV-1 MONITOR TEST KIT V1.5 21118560018 manufactured by Roche Molecular Systems, Inc..
[387910]
Several technicians in one customer's laboratory complained of heart palpitations, chest pain and shortness of breath during sample preparation allegedly caused by fumes given off form the sample preparation reagents contained in the amplicor hiv-1 monitor test kit v1. 5. The customer suggests that since the lysis buffer in the kit contains guanidine thiocynate that this may be possible source of noxious fumes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2004-00003 |
| MDR Report Key | 596013 |
| Report Source | 05,06 |
| Date Received | 2004-06-03 |
| Date of Report | 2004-06-02 |
| Date of Event | 2004-02-05 |
| Date Facility Aware | 2004-02-05 |
| Report Date | 2004-06-02 |
| Date Reported to Mfgr | 2004-02-10 |
| Date Mfgr Received | 2004-02-10 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2005-04-28 |
| 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 | 3 |
| Manufacturer Contact | KAREN LONG |
| Manufacturer Street | 4300 HACIENDA DR. |
| Manufacturer City | PLEASANTON CA 945660900 |
| Manufacturer Country | US |
| Manufacturer Postal | 945660900 |
| Manufacturer Phone | 9257308110 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMPLICOR HIV-1 MONITOR TEST KIT V1.5 |
| Generic Name | IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR HIV-1 RNA |
| Product Code | MTL |
| Date Received | 2004-06-03 |
| Model Number | NA |
| Catalog Number | 21118560018 |
| Lot Number | E011863 |
| ID Number | NA |
| Device Expiration Date | 2004-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 585830 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 U.S. HWY. 202 SOMERVILLE NJ 08876 US |
| Baseline Brand Name | AMPLICOR HIV-1 MONITOR V1.5 |
| Baseline Generic Name | MONITOR TEST, HIV-1 |
| Baseline Model No | NA |
| Baseline Catalog No | 21118560018 |
| Baseline ID | LOT NO. E011863 |
| Baseline Device Family | AMPLICOR HIV-1 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-03 |