MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-12-04 for REALTIME HIV-1 manufactured by Abbott Molecular, Inc..
[18217177]
To conclude, this thermal non-uniformity can result in possible-mis-quantitation too low for low-level samples when using the realtime assay when a fill state of 49 to 88 specimens on the 96-well pcr plate on the m2000rt instrument. Importantly, the low-level samples are accurately quantitated when running a fill state of 48 or 96 wells on the 96-well pcr plate using the realtime hiv-1 assay on the m2000rt instrument.
Patient Sequence No: 1, Text Type: N, H10
[18370585]
A determination was made that thermal non-uniformity existed across the 96-well pcr plate when using the m2000rt instrument. This thermal non-uniformity can result in possible mis-quantitation too low for low level samples when running the realtime assay when using a fill state of 49 to 88 specimens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005248192-2008-00005 |
| MDR Report Key | 1257470 |
| Report Source | 07 |
| Date Received | 2008-12-04 |
| Date of Report | 2008-12-02 |
| Date of Event | 2008-11-04 |
| Date Mfgr Received | 2008-07-23 |
| Date Added to Maude | 2009-08-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA MARTIN |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617333 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REALTIME HIV-1 |
| Generic Name | RT-PCR ASSAY FOR HIV-1 QUANTITATION |
| Product Code | MTL |
| Date Received | 2008-12-04 |
| Returned To Mfg | 2008-07-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-12-04 |