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

Model Number 08H00-01

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

The customer observed discrepant hemoglobin results generated on the cell-dyn sapphire analyzers for one patient.The customer stated the same sample was used for both analyzers.The customer does not know which result is correct.The following data was provided: (b)(6) 2022 sid (b)(6) initial result (42840az) = 6.37 g/dl, (b)(6) 2022 sid (b)(6) repeat result (60016az) = 11.1 g/dl.No impact to patient management was reported.

Manufacturer Narrative

Patient identifier: sids = (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The investigation included a review of data and information provided by the customer, trending review, product historical record review, and product labeling review.Ticket trending review did not identify any trends for the issue for the product.Product history record review did not identify a product issue related to the complaint.Labeling was reviewed and sufficiently addresses the customer's issue.The customer provided printed specimen reports for sid (b)(6) (seq 8612, s/n (b)(6)) and specimen id (sid) (b)(6) (seq 6733, s/n (b)(6)).Review of the specimen reports found that the retest results (run in open mode) are not comparable to the initial test (run in closed mode).In addition to the discrepant hemoglobin (hgb) results, red blood cell (rbc), white blood cell (wbc), and platelet (plt) results were lower as well, which might indicate a possibility of impacted preanalytical factors such as mixing and handling.The retest run generated several suspect (*) results for wbc and differential, with nvwbc, blast, fp?, and varlym flags.Review of the scatter indicated the degradation of the sample likely occurred.The sample storage condition is unknown.Per section 7, operational precautions and limitations, of the cell-dyn sapphire operator¿s manual, the sample stability for wbc/wbc differential, rbc, hgb, plt, and their associated parameters is 36 hours.In this complaint case, the retest was performed approximately 72 hours after the initial run, thus, the results on the retest were not reliable for the comparison to the initial run.Per section 1, use or function, of the cell-dyn sapphire operator¿s manual, under sample dilution and analysis: for both autoloader and open tube modes, the analyzer aspirates a nominal volume of 120 l of blood through the aspiration probe.¿short sample¿ error message indicating insufficient sampling volume was not generated for both runs.There was no indication to show that low sample volume was an issue in this complaint.Based on the information provided, preanalytical factors could not be ruled out as contributing factors to the discrepant results.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number (b)(6) 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: 16286023
• MDR Text Key: 308775096
• Report Number: 2919069-2023-00004
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• 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: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CDS/R/4K DIL/SHT, 01H73-01, UNKNOWN; CDS/R/4K DIL/SHT, 01H73-01, UNKNOWN