MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000SP; CLINICAL SAMPLE CONCENTRATOR

Catalog Number 09K14-02

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2015

Event Type  malfunction  

Event Description

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.An abbott field service engineer (fse) visited a customer site and observed a burned area on a dc servo board (see attachment 1 photo dc servo board).The fse replaced the board and restored the m2000sp instrument to its operating condition.There was no death or injury reported.

Manufacturer Narrative

Elevated complaint investigation 4369-ecinv is in progress for this issue.An mdr follow-up report will be submitted after finalizing the complaint investigation.

Manufacturer Narrative

Elevated complaint investigation (ecinv) (b)(4) report summary for mdr 3005248192-2015-00003 follow-up report 1: investigation into this complaint included a quality data review, a product evaluation, and a complaint history review.The results of the investigation are summarized as follows: quality data review: material specification documents were identified for the impacted instrument and spare parts.There is an adequate process to receive and approve each of these parts into inventory.Review of the operations manual shows the customer is instructed to call their local service representative in case of the liha will not initialize with a probable cause of hardware failure.Additionally, there are instructions in the service manual for the fse to troubleshoot this issue and replace boards.A review of the service history was performed for the m2000sp e series 09k14-02 (sn (b)(4)).Upon review of each ticket there were no complaints documenting a failure of component ic3 on the pcba dc servo ii board (pn 10649011).A nonconformance / capa search was performed for the m2000sp instrument system, m24sp instrument system and the plex id instrument system.Review of the records identified in the searches shows 1 capa record ((b)(4)) was related to burned servo boards.(b)(4) documents the vendor investigation and risk assessment performed by supplier tecan, ag for tantalum capacitor failures on the pcba dc servo ii power (pn 10649012) and pcba dc servo ii (pn 10649011) circuit boards.The elevated complaint associated with this investigation is not due to tantalum capacitor failures; rather it is due to failure of integrated circuit component ic3 on the pcba dc servo ii (pn 10649011) circuit board.Therefore, (b)(4) is not relevant to this investigation.Product evaluation: review of photographs attached to the complaint ticket indicated the damage was limited to the pcba dc servo ii board (pn 10649011).There were no observations of charring or soot external to the m2000sp e series 09k14-02 (sn (b)(4)).The charring was limited to ic3 on the pcba dc servo ii board which selfextinguished.A metal enclosure surrounding the pcba dc servo ii board is an additional engineering control to prevent the spread of fire should fire occur.Additionally, 100% of these circuit boards are tested on an in-circuit test system prior to release from the vendor.Therefore, the m2000sp e series 09k14-02 (sn (b)(4)) operated as designed.No product deficiency was identified.Tecan was notified of this reported complaint.The attached tecan notification determined component ic3 failed due to over current.Complaint history review: complaint history review showed that, over the last 2 years, only the elevated complaint ((b)(4)) was related to the issue of any pre flags set as a result of smoke, discoloration, or fire occurring with component ic3 on the pcba dc servo ii board (pn 10649011), and the pcba dc servo power ii board (pn 10649012) which are used on the m2000sp e-series (09k14-02) instrument, the m24sp instrument system (03n06-01), and the plex-id fluid handler (03n31-50).Product deficiency decision based on the results of the investigation elements the product conforms to safety standard iec 61010-1.A product deficiency was not identified for the m2000sp e series 09k14-02 (sn (b)(4)) or any abbott molecular products containing the pcba dc servo ii board (pn 10649011) or the pcba dc servo ii power (pn 10649012) circuit board.Therefore, the disposition of this complaint is unconfirmed.

• Brand Name: ABBOTT M2000SP
• Type of Device: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 331
• Manufacturer (Section G): ABBOTT MOLECULAR, INC.; 1300 east touhy avenue; des plaines IL 60018 331
• Manufacturer Contact: jean leete ; 1300 east touhy avenue; des plaines, IL 60018-3315 ; 2243617274
• MDR Report Key: 4525349
• MDR Text Key: 17221009
• Report Number: 3005248192-2015-00003
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K092705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1