MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-29 for 3M INTEGRATED CYCLER MOL1001 manufactured by Focus Diagnostics, Inc..
[20977239]
The customer reported that they were changing the laptop computer and ran an assay without importing the spectral matrix. They obtained flu a and flu b positive results. They repeated the sample on another unit and the results were flu a positive and flu b negative. After updating the spectral matrix on the new laptop, the results were positive for flu a and negative for flu b. The flu a and flu b positive results were not reported to the doctor. The product insert was revised to advise the end-user that the spectral matrix must be installed for each integrated cycler unit.
Patient Sequence No: 1, Text Type: D, B5
[21439390]
Investigation determined that the integrated cycler studio software inadvertently allowed the user to manually enter any spectral matrix, which could be incorrect. The spectral matrix is unique to each integrated cycler instrument. The spectral matrix is provided with the integrated cycler on the cover of the user's manual. The spectral matrix must be installed in each integrated cycler instrument and should not be changed unless an updated code is provided by focus diagnostics. The product insert warning and precautions section has been revised to include the following states: the spectral matrix must be installed in each 3m integrated cycler and should not be changed unless an updated qr code for the instrument is provided by focus diagnostics. The spectral matrix is unique to each 3m integrated cycler. The spectral matrix was provided with the 3m integrated cycler instrument on the cover of the 3m integrated cycler hardware manual. If the matrix label will not scan or cannot be found contact focus diagnostics. The contact info is on the last page of this document. Not installing or changing the spectral matrix can result in false results. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023365-2014-00048 |
| MDR Report Key | 4379433 |
| Report Source | 05 |
| Date Received | 2014-12-29 |
| Date of Report | 2013-12-05 |
| Date of Event | 2013-12-05 |
| Date Mfgr Received | 2014-05-05 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2015-01-15 |
| 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 | VALERIE CIMMARUSTI, CLS |
| Manufacturer Street | 11331 VALLEY VIEW ST. |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal | 90630 |
| Manufacturer Phone | 5622406484 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1958-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M INTEGRATED CYCLER |
| Generic Name | RT NUCLEIC ACID AMPLIFICATION SYSTEM |
| Product Code | OOI |
| Date Received | 2014-12-29 |
| Model Number | MOL1001 |
| Catalog Number | MOL1001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOCUS DIAGNOSTICS, INC. |
| Manufacturer Address | CYPRESS CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-29 |