MAUDE Adverse Event Report: ABBOTT MOLECULAR, INC. ABBOTT M2000RT; INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS

Catalog Number 09K15-01

Device Problems Material Discolored (1170); Overheating of Device (1437)

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

Event Date 04/07/2015

Event Type  malfunction  

Event Description

The abbott m2000 realtime 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.A field service specialist (fss) performed lamp, lamp socket/cable assembly, lamp-gemini cord with connector replacement as per (b)(4).Visual verification showed a brown coloration of the lamp socket that required replacement.The pca microcontroller verification procedure show significant signs of overheating ( brownish ) of the connector for the lamp power.Performed pca microcontroller replacement as per m2000rt service manual.All checks and calibrations passed, instrument working per specification.There was no death or injury.A malfunction may have occurred.Elevated complaint investigation (b)(4) is in progress to investigate the observed evidence of overheating.

Manufacturer Narrative

An elevated complaint investigation (b)(4) is in progress.It is unknown at this time if this observation was caused by an abbott product malfunction.If an abbott product malfunction is identified then further evaluation will determine if recurrence of the malfunction is likely to cause death or serious injury.

Manufacturer Narrative

Summary of (b)(4) for mdr 3005248192-2015-00009 follow-up report 1: investigation into this complaint included a quality data review, a product evaluation, complaint history review and a service history review: quality data review.Device history record / batch record review: valid material specifications reside in pilgrim smartsolve for the lamp - gemini board cable with connector and the pca microcontroller board.A service history review was performed for the m2000rt instrument system, sn (b)(4).(b)(4) was reviewed and shows appropriate instructions for troubleshooting 4448 error codes and potential for observed discoloration.Capa / non-conformance review: a nonconformance / capa search was performed for the m2000rt instrument system ((b)(4)).Review of the records identified in the searches determined all entries were not related.A nonconformance / capa search was performed for the lamp - gemini board cable with connector ((b)(4)).Review of the record identified in the searches determined it was not related.A nonconformance / capa search was performed for the pca microcontroller board ((b)(4)).No additional records were identified.Product/system/instrument evaluation: return sample evaluation: the lamp - gemini board cable with connector and the pca microcontroller board were returned for evaluation.The instrument meets required safety certifications.The returned parts are contained inside a metal enclosure per required safety standards.The instrument functioned as designed and failed safe.This is a case of discoloration due to localized heating of the lamp-gemini board cable with connector due to aging.Complaint history review showed that, over the last 2 years, only the elevated complaint ((b)(4)) was related to the issue of any potential reportable event (pre) flags set as a result of smoke, discoloration, or fire occurring on the m2000rt instrument system ((b)(4)).Complaint history review showed that, over the last 2 years, the elevated complaint ((b)(4)) and (b)(4) additional complaints were related to browning/discoloration of the lamp cable connector.Note: browning or discoloration of the lamp cable connector may occur due to localized heating over time and is documented in (b)(4) instructs the field service engineer (fse) to replace the lamp - gemini board cable with connector if browning or discoloration of the connector is observed.Product deficiency decision: discoloration may occur due to localized heating of the lamp-gemini board cable with connector over time and is documented in (b)(4).The instrument meets required safety certifications.The indicated parts were contained within a metal enclosure and failed safe.Based on the results of the investigation, a product deficiency was not identified.Therefore, the disposition of this complaint is unconfirmed.

• Brand Name: ABBOTT M2000RT
• Type of Device: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS
• 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: 4746791
• MDR Text Key: 5704242
• Report Number: 3005248192-2015-00009
• Device Sequence Number: 1
• Product Code: JJH
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 09K15-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2015
• 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