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

Catalog Number 08H67-03

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

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 stated that intermittent falsely elevated platelet results were generated for patient samples tested on the cell-dyn ruby analyzer.No adverse impact to patient management was reported.Patient id (b)(6).Female, date of birth (b)(6) 1989.Sample tested on (b)(6) 2016.Initial platelet result = 1953 10e9/l, repeat platelet result = 231 10e9/l.Patient id (b)(6).Female, date of birth (b)(6) 1939.Sample tested on (b)(6) 2016.Initial platelet result = 1014 10e9/l, repeat platelet result = 515 10e9/l.

Manufacturer Narrative

Investigation consisted of review of submitted data, product historical data and product labeling.No adverse trends or abnormal complaint activity was identified for the customer issue.Review of the scatter on the submitted data showed possible bacterial contamination.The scatter gram showed a population classified as microcytic plt, which are most likely colonies of bacteria.It is unknown what troubleshooting was performed between the initial and repeat runs to cause the plt results to generate expected plt results on the repeat run.The complaint information stated that after each troubleshooting was performed, the issue goes away but, will continuously re-occur in time.This is probably due to the re-growth of bacterial contamination inside the analyzer.It is unknown what may have caused the bacterial contamination in the analyzer.Decontamination of the instrument was recommended.A review of labeling concluded that the issue is sufficiently addressed.Based on available information and data, the investigation concluded the complaint was an instrument-specific issue which involved bacterial contamination.No product deficiency was identified.

Event Description

An additional occurrence was observed on (b)(6) 2017.An initial platelet result of 1342 10e9/l retested at 341 10e9/l.No adverse impact to patient management was reported.

• Brand Name: CELL-DYN RUBY 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: 6165463
• MDR Text Key: 62376082
• Report Number: 2919069-2016-02310
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740099916
• UDI-Public: 00380740099916
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061667
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08H67-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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: 27 YR