MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS DIVISION CELL-DYN 3700 SL ANALYZER; AUTOMATED HEMATOLOGY ANALYZER

Catalog Number 02H31-03

Device Problem Charred (1086)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up report will be submitted when the evaluation is complete.

Event Description

An abbott field service engineer (fse) indicated there was evidence of charring on the electronics board of the cell-dyn 3700sl analyzer.No injuries have been reported.

Manufacturer Narrative

Further investigation of the customer issue included a review of the complaint text, review of the returned part, field service evaluation, a search for similar complaints, and a labeling review.The returned wbc impedance module (wim) was evaluated along with photos of the part and showed the capacitor showed a burn mark, that insulation had peeled off, evidence of liquid splashed and residue deposits.No adverse trends were identified for the part in question, as this was the only documented event for this type of incedent.Labeling was reviewed and found to be adequate, as it contains instructions regarding electrical hazard awareness and elements of electrical safety information relevant to the complaint incident.Based on the available information no product deficiency of the cell-dyn 3700sl analyzer, list number 02h31, and the related wbc impedance module, was identified.

• Brand Name: CELL-DYN 3700 SL ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5294321
• MDR Text Key: 34017652
• Report Number: 2919069-2015-00087
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: BA
• PMA/PMN Number: K980614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02H31-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1