MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-03 for ABBOTT M2000SP 09K14-02 manufactured by Abbott Molecular, Inc..
[24939332]
Elevated complaint investigation (ecinv) (b)(4) is in progress for this issue. An mdr follow-up report will be submitted after finalizing the complaint investigation.
Patient Sequence No: 1, Text Type: N, H10
[24939333]
The abbott m2000 system is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is composed of the m2000rt and the m2000sp instruments. The m2000sp is intended for automated sample preparation and nucleic acid extraction prior to testing. A customer reported that when turning on an abbott m2000sp instrument after it had been turned off for three days, the instrument stayed in an offline status without any error. An abbott field service engineer (fse) inspected the instrument and observed a damaged fuse and diluter. The photo of the damaged fuse and diluter (see attachment a ) suggests possible signs of charring and overheating. It is unknown at this time if this observation was caused by an abbott product malfunction or if the device failed safely as designed. An abbott molecular elevated complaint investigation is in process. Although no death or injury occurred, this event is being reported on the basis of the potential for death or serious injury to occur if the malfunction is confirmed and should it recur.
Patient Sequence No: 1, Text Type: D, B5
[34029424]
Summary of elevated complaint investigation (ecinv) (b)(4) for mdr 3005248192-2015-00018 follow-up report 1: investigation into this complaint included a product/system/instrument evaluation, quality data review, and a complaint history review to determine a product deficiency decision. Product/system/instrument evaluation: this event was resolved through routine replacement of the dilutor and fuse 2. The charred component on the dilutor circuit board was contained within the metal enclosures of the m2000sp e series and the components self-extinguished per design controls. The diluter meets safety requirements for protection against the spread of fire per en 61010-1. The dilutor failed safe as designed. Quality data review: the m2000sp operations manual 200681-108 november 2014, page xviii, contains the safety certifications for the m2000sp e series 09k14-02. The m2000sp e-series service manual 50-608125/r4 october 2012, page 7-60 begins troubleshooting information for the dilutor. Page 9-198 begins complete dilutor removal, replacement and verification instructions. Fuse location and replacement instructions are found on page 9-20. Nonconformance/capa search found no related entries. Service history review indicated a successful installation and only this instance of the dilutor xp smart, part 10649015 replacement due to a damaged circuit board. Complaint history review: complaint history review showed over the last 2 years, this complaint and one additional complaint were related to the issue of potentially reportable event flags set as a result of failure of the dilutor. The related complaint was unconfirmed per elevated complaint investigation (b)(4). Product deficiency decision: abbott molecular elevated complaint investigation ((b)(4)) for this event determined the dilutor failed safe and that this complaint is unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005248192-2015-00018 |
| MDR Report Key | 5053515 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-03 |
| Date of Report | 2015-10-08 |
| Date of Event | 2015-08-09 |
| Date Mfgr Received | 2015-09-25 |
| Date Added to Maude | 2015-09-03 |
| 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 | JEAN LEETE |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal | 600183315 |
| Manufacturer Phone | 2243617274 |
| Manufacturer G1 | ABBOTT MOLECULAR, INC. |
| Manufacturer Street | 1300 EAST TOUHY AVENUE |
| Manufacturer City | DES PLAINES IL 600183315 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600183315 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABBOTT M2000SP |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2015-09-03 |
| Returned To Mfg | 2015-09-09 |
| Catalog Number | 09K14-02 |
| Device Availability | R |
| 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 600183315 US 600183315 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-03 |