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

Catalog Number 08H00-01

Device Problem Low Test Results (2458)

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

Event Date 08/18/2019

Event Type  malfunction  

Manufacturer Narrative

Patient identifiers: (b)(6).Sid (b)(6) is male and date of birth is (b)(6).Sid (b)(6) is female and date of birth is (b)(6).All available patient information has been included.No additional patient information is available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false decreased wbc results when processing on the cell-dyn sapphire.The following data was provided: sid (b)(6) (dob (b)(6), male): initial wbc result 0.006 10e9/l and retest was 9.38 10e9/l.Additional testing was provided for this patient: rbc 4.37 - 4.39 10e12/l, hgb 8.27 - 8.37 mmol/l, mcv 94.0 - 93.6 fl, and plt 197 - 186 10e9/l.Sid (b)(6) (dob (b)(6), female): initial wbc result 0.023 10e9/l and retest was 14.0 10e9/l.Additional testing was provided for this patient: rbc 4.25 - 4.20 10e12/l, hgb 7.27 - 7.19 mmol/l, mcv 85.1 - 85.0 fl, and plt 128 - 128 10e9/l.No impact to patient management was reported.

Manufacturer Narrative

An investigation was performed for the customer issue and included a review of the complaint text, a review of product historical data, and a review of product labeling.Review of historical data did not find a product issue related to the complaint incident.A review of the historical data on the instrument s/n: 42683az found the preventative maintenance was performed on the instrument after this ticket opened.No returns were available.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation a product deficiency was not identified.

• Brand Name: CELL-DYN SAPPHIRE ANALYZER
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 8957242
• MDR Text Key: 184178250
• Report Number: 2919069-2019-00099
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

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: 08H00-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/21/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1