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

Catalog Number	02H31-03
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2019
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.There is no further patient information provided due to privacy issues.
Event or Problem Description
The customer reported a falsely decreased hematocrit (hct) result on one patient.The results provided were: (b)(6) 2019 = 23.6 / 24.5.The customer stated that the patient was transfused as policy is to transfuse patients with hcts <28.The sample was repeated in the afternoon and the hct results were 30.2 / 34.3.There was no adverse impact to the patient reported due to the unnecessary transfusion.
Additional Manufacturer Narrative
During the subsequent site visit, the field service engineer (fse) resolved the issue by replacing the tubing in the pinch valve above the open mode probe (part number 9130542).A review of instrument status determined that the recommended preventive maintenance has not been performed on this instrument, which includes replacement of the tubing affected.Return testing was not completed as returns were not available.A review of the cell-dyn 3700 system operator's manual found labeling to be adequate for the complaint issue.A search for similar complaints did not identify any additional complaints or trends associated with this issue.Based on the investigation there is no product deficiency identified for the cell-dyn 3700, serial number (b)(4).

• 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: 8523435
• Report Number: 2919069-2019-00035
• Device Sequence Number: 16843802
• Product Code: GKZ
• UDI-Device Identifier: 00380740002732
• UDI-Public: 00380740002732
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: Health Professional
• Device Catalogue Number: 02H31-03
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/16/2019
• 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: Other