MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-11-14 for ABBOTT M2000RT 09K15-01 manufactured by Abbott Molecular, Inc..
[2920823]
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Patient Sequence No: 1, Text Type: D, B5
[3168762]
The abbott m2000 system is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the abbott m2000sp and abbott m2000rt instruments. The abbott m2000sp instrument is an automated fluid handling system for performing sample preparation for nucleic acid testing. The abbott m2000rt system software is an automated system for performing fluorescence-based pcr that results in quantitative and qualitative detection of nucleic acid sequences. During service on the abbott m2000rt system software, the field service engineer disassembled the heated cover. He removed the fresnel lens and noticed a burnt/charred mark on the lens above wells a8 and a9, directly above where the ribbon cable is connected. No fire or visible smoke was observed. There was no report of injury. The burnt/charred mark on the lens is considered to be evidence of fire. Evidence of fire is criteria for an mdr reportable event per abbott molecular procedure.
Patient Sequence No: 1, Text Type: D, B5
[10576336]
On (b)(4) 2013, fda telephoned abbott molecular to bring to our attention that the 3500a form for mdr 3005248192-2012-00026 was missing the event description. Additionally, there was a single letter "t" entered. The single letter "t" observed should have been deleted. Both mistakes were attributed to human error. An additional step to prevent this mistake from occurring again is to print out the form from e-submitter to check it before submitting it to fda through web trader.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2012-00026 |
| MDR Report Key | 2832344 |
| Report Source | 07 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-10-22 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2013-02-25 |
| Date Added to Maude | 2013-02-25 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JEAN LEETE |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 E. TOUHY AVE. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000RT |
| Generic Name | INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS. |
| Product Code | OOI |
| Date Received | 2012-11-14 |
| Catalog Number | 09K15-01 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MOLECULAR, INC. |
| Manufacturer Address | 1300 E. TOUHY AVE. DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-14 |