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

Catalog Number	09K14-02
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An elevated complaint investigation will be performed.
Event or Problem Description
The customer reported an incident that a lab technician was disposing the red hazardous bag from the m2000sp instrument to their waste bag for hazardous goods to be sent for incineration, and a tip ripped through the red bag and her gloves which cut her finger.The customer stated that the lab technician was taking out the solid waste bag and transferring it to another bag.The technician pushed down on the bag, which caused the puncture of the tip through the bag and the technician's glove.They were testing (b)(6) samples.The customer reported it was a superficial scratch on their finger, and there was evidence of blood.The customer completed an internal investigation of their process for waste disposal.The customer believed it was an internal handling issue rather than an incident caused by an abbott product deficiency.The customer has since changed their internal practice for solid waste disposal.The customer blames internal waste handling and not abbott for this reported incident.The lab technician went to occupational health, and testing and precautions were completed.The customer stated that the affected user received (b)(6) prophylaxis, hbv booster injection, and baseline blood was taken.The user will be tested in a month for blood borne viruses.No patient was involved, injury was sustained by an abbott m2000sp instrument user.This incident is being reported to fda because the incident occurred in united kingdom using the m2000sp instrument, list number 09k14-02, which is also approved for use in the united states.
Additional Manufacturer Narrative
Investigation into this complaint included an existing data review, a quality data review, product/system/instrument evaluation, a customer data review, and a complaint history review.Investigation is summarized as follows: existing data review: m2000sp instrument operations manual 200681-109 - march 2016 (list number (ln) 09k20-009), was reviewed.Review concluded the manual contains adequate instructions for the use of consumable biohazard bags and related warnings.·biological risks [warning]: the m2000sp waste is potentially infectious.Use appropriate biohazard precautions, is provided in section 1, use or function, liquid handling system, waste system, beginning on page 1-38; and are provided throughout the manual.·biological risks [warning]: the ditis can potentially puncture a disposable biohazard bag.Double-bagging the ditis is recommended, is provided in section 1, use or function, cabinet, solid waste container, beginning on page 1-57.·note: to ensure proper function of the m2000sp, only consumables supplied by abbott should be used.Optional consumables including disposable biohazard bags, is provided in section 1, use or function, required consumables, beginning on page 1-61.Quality data review: the two non-conformance/capa history review searches for the m2000sp instrument system, ln 09k14-02, found no related entries.Product/system/instrument evaluation: a review of m2000sp sn 10480, service tickets since the installation on (26 sept 2011) at the present customer site in birmingham, united kingdom revealed no additional related tickets.Customer data review: the customer statement provided reveals the waste bag was completely removed from the instrument and was in the processes of being placed into a second yellow waste bag, for incineration, when the reported issue occurred.The customer has since changed their internal practice for solid waste disposal.A review of photographs provided was completed.Complaint history review: complaint history review showed that the elevated complaint under investigation is the only investigation related to a physical injury from a tip that pierced through the waste bag and glove while transferring the waste bag of an m2000sp instrument system, ln 09k14-02.Based on the results of this investigation, no product deficiency for the m2000sp instrument system, ln 09k14-02, was identified.

• Brand Name: ABBOTT M2000SP INSTRUMENT
• Common Device Name: CLINICAL SAMPLE CONCENTRATOR
• Manufacturer (Section D): ABBOTT MOLECULAR, INC.; 1300 e. touhy ave.; des plaines IL 60018 3315
• MDR Report Key: 8354169
• Report Number: 3005248192-2019-00003
• Device Sequence Number: 2371276
• Product Code: JJH
• UDI-Device Identifier: 00884999031753
• UDI-Public: 00884999031753
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 09K14-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention