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

Catalog Number 09K14-02

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437); Device Inoperable (1663)

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

Event Date 04/20/2015

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.On (b)(9) 2015, a customer reported that an m2000sp instrument froze during a processing step for a sample extraction.The abbott field service engineer (fse) inspected the instrument and observed a burnt integrated circuit.The dc-servo board was replaced.On (b)(6) 2015, the instrument failed in the same position (magnetic rest) but in a different step during processing.The fse determined that the dc-servo ii board of the left robotic manipulator arm (roma) backplane was not functional.The fse observed that the resistor overheated and the flex cable was slightly melted.On (b)(6) 2015, the instrument failed in the same position (magnetic rest) but in a different step during processing.The fse observed that the dc-servo ii board of the left roma backplane was not functional.The dc-servo board appeared burnt and was replaced.After this replacement the instrument has operated as intended.There was no death or injury reported.Elevated complaint investigation (b)(4) is in process.

Manufacturer Narrative

Elevated complaint investigation (b)(4) is in progress for this issue.An mdr follow-up report will be submitted after finalizing the complaint investigation.

Manufacturer Narrative

(b)(4) included a quality data review, a product labeling review, a product evaluation and a complaint history review.Photographs showed that damage was limited to the pcba dc servo ii board and the flex cable.The pcba dc servo ii board failed due to over current and self-extinguished as designed.Replacement of a component of the robotic manipulator arm eliminated all possible causes of failure (over current).There were no observations of overheating external to the m2000sp instrument.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.The product conforms to safety standard iec 61010-1.Based on complaint investigation (b)(4), the m2000sp e series 09k14-02 (sn (b)(4)) operated as designed and failed safe.No product deficiency was identified.

• 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: 4771938
• MDR Text Key: 5785763
• Report Number: 3005248192-2015-00012
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1