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

Model Number 08H67-01

Device Problem Incorrect Measurement (1383)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

There was no further patient information provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed discrepant platelet and hemoglobin results on ruby analyzer when compare to beckman coulter analyzer for one patient.The results provided were: on (b)(6) 2021 sid (b)(6) plt=5.23 k/ul/repeated on beckman coulter lh700 and dxh800=556 k/ul hemoglobin=8.55 g/dl /repeated=7.7 g/dl all cbc data provided was reviewed and no other parameters meet reporting criteria.There was no impact to patient management reported.

Manufacturer Narrative

A review of the tracking and trending report determined that there are no trends for the product for the complaint issue.Review of the attached data found that plt and/or hgb were either suspect (marked with beside the numerical result) or fell above or below the normal patient limit set by the user (results underlined).All the flags indicate that the verification/validation of these results would be required per the laboratory¿s protocol.It was also noticed that discrepant results occurred more often on samples collected via finger stick/heel stick.Due to very limited sample volumes collected in these manners, sample mixing could be a factor that could potentially contribute to the discrepant results between the first run on the cd ruby and the second run on the beckman coulter instrument.The cd ruby and beckman coulter analyzers use different technologies to measure plt and hgb, mainly optical vs impedance, respectively.The difference in the results between the cd ruby and beckman coulter analyzers may be due to the sample cell morphology/pathology and the different technologies used.No instrument issue identified during the site visit by abbott field service (fsr).A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the ruby analyzer, serial number (b)(6).

• Brand Name: CELL-DYN RUBY SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): ABBOTT LABORATORIES; 4551 great america parkway; santa clara CA 95054
• MDR Report Key: 12281043
• MDR Text Key: 265174981
• Report Number: 2919069-2021-00015
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• PMA/PMN Number: K061667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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 Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 MO