MAUDE Adverse Event Report: ABBOTT LABORATORIES CELL-DYN SAPPHIRE SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number 08H00-01

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer was experiencing instrument error messages (0635 diluent/sheath reagent reservoir #1 failed to fill) since june 2, 2022 on the cell - dyn sapphire.Prior to the call, the customer had drained and filled the reservoir and changed the consumable.The customer is now generating the error code more frequently.There was another instrument error code 0632 wbc reagent ¿ part b not detected and more resistant rbc flags on the sapphire instrument.There was one discrepant wbc result for a patient sample.The results were: 07jun2022 sid 1104871570: initial wbc: 0.356, repeat on another sapphire: 13.59, previous result: 13.0 (reference range: 4.0-11.0).There was no impact to patient management reported.

Manufacturer Narrative

The investigation included a review of the submitted data, product historical data, and product labeling.Review of the submitted specimen report found that limit set flags, suspect parameter flags, ig and band suspect population flags, and the invalid data message, "unable to find clear separation between wbc subpopulations", were displayed.These data flags and messages indicated that further review and validation of the results was required.Field service resolved the observed issue by replacing the leaking wbc mix cup (assy, mix pot, cdsphr, rohs, list number 8921287102) on the cell dyn sapphire.Review of the historical data did not find a product issue related to the complaint incident.Review of tracking and trending did not identify any related trends associated with the complaint issue.Increase in complaint activity for the complaint issue was not identified.A device history record was reviewed and did not identify a product issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency was identified.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer (Section G): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 14750746
• MDR Text Key: 302962430
• Report Number: 2919069-2022-00015
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08H00-01
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1