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

Catalog Number 08H00-01

Device Problem Incorrect Measurement (1383)

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

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 reports scatter in the measurement of cd3t t cells/cd4t t cells/cd8t t cells parameters on a cell-dyn sapphire analyzer for one male patient in his forties (due to confidentiality, the patient's diagnosis would not be disclosed).The scattered measured values are, however, within normal expected ranges.None of the values are flagged and there are no issues with the moving average indicator.Review of the scattergrams indicates possible platelet aggregates or hama interference.The following was provided generated from one collected sample retested three times: run 1 cd3=.572 32.4%, cd4=.160 9.08%, cd8=.289 16.4% 4/8=0.555, run 2 cd3=.657 34.5%, cd4=.290 15.3%, cd8=.337 17.7% 4/8= 0.863, run 3 cd3= 0804 40.1%, cd4=.408 20.3%, cd8= 0356 17.7% 4/8= 1.15.There is no impact to patient management reported.

Manufacturer Narrative

The customer reported an issue related to the scatter in the measurement of cell-dyn immuno t-cell (cd3/4/8) reagent for one patient sample which was run three times.Although the results of the three runs were within standard values, the scatters in the runs showed obvious differences.The customer stated that no other patient results were affected, reagents were ruled out as cause, and moving averages are within expected ranges.The customer also suspects the presence of platelet aggregates or human anti-mouse antibodies (hama) interference.Review of submitted data showed the neutrophil population came down very low in the second run when compared to the neutrophil populations in the initial and third runs.It was also observed that the affected scatters and results on the three runs were the cd3/4 results and not the cd3/8 results.The cell-dyn sapphire operators manual provides instructions to ensure the cd3/4 and cd3/8 reagents are not compromised by temperature and moisture.Based on this observation, a pre-analytic issue, like a compromised cd3/4 reagent, could not be eliminated.Also, the possible presence of interfering substances and conditions could not be eliminated as a possible contributing factor for the complaint incident.The investigation included review of submitted data, review of product historical data and product labeling, as well as, consultations with subject matter experts from medical affairs and research and development (r&d) departments.Review of product historical data for any trends and all customer complaints received for this issue did not identify any adverse trends or abnormal complaint activity.Based on the results of this evaluation and the information from the customer site, there is evidence to reasonably suggest a product malfunction occurred as the device failed to meet performance specifications or otherwise perform as intended at the customer site.However, no systemic issue or product deficiency was 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
• Manufacturer (Section G): ABBOTT DIAGNOSTICS DIVISION; 4551 great america parkway; santa clara CA 95054
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 6591029
• MDR Text Key: 75970229
• Report Number: 2919069-2017-00092
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR