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

Catalog Number	02H31-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer stated that the cd3700 analyzer generated a falsely elevated platelet result on one patient in the closed mode.The initial result was 950 k/ul.The customer performed a manual smear and observed no platelets, so they reran the sample and the result was 300 k/ul.There was no reported impact to patient management.There was no additional patient information provided.
Additional Manufacturer Narrative
The customer observed falsely elevated platelet results on a patient sample run in the closed mode compared to a manual differential.A site visit by field service found that the cable of the left front cover was cut.Field service replaced the cable resolving the issue.There were no customer returns available for this investigation.A review of service complaints for the cd3700 analyzer, the left front cover, list number 8932086101, or the cable, list number 8952077901 did not identify any other complaints or trends for this issue.A review of the cell-dyn 3700 operator's manual provides the operator with adequate troubleshooting for inaccurate or imprecise rbc/mcv/plt data.Based on this investigation a product deficiency was not identified for the cell-dyn 3700, list number 02h31-01, the left front cover, list number 8932086101, or the cable, list number 8952077901.

• Brand Name: CELL-DYN 3700 SL ANALYZER
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 6055196
• Report Number: 2919069-2016-02236
• Device Sequence Number: 13459819
• Product Code: GKZ
• UDI-Device Identifier: 00380740002725
• UDI-Public: 00380740002725
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K980614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 02H31-01
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1