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

Model Number 08H67-01

Device Problem High Test Results (2457)

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

Event Date 12/29/2021

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 observed a falsely elevated platelet result generated on the cell dyn ruby for one sample.The following data was provided: initial platelet result = 1486 k/ul, repeat = 300 k/ul.Additional laboratory data was provided: hemoglobin =10 g/dl, hematocrit = 24%.No impact to patient management was reported.

Event Description

Further clarification was provided by the customer: (b)(6) 2022 sid (b)(6): platelet: (b)(6) = 1486* 10e/ul (k/ul), repeat results on the sapphire = 386 10e3/ul additional laboratory data was provided: hemoglobin: (b)(6) = 10.7* g/dl, repeat on the sapphire = 10.0 g/dl the results generated on cell dyn ruby included a data invalidating flag (*).

Manufacturer Narrative

Further clarification was provided by the customer and sections a1 patient identifier and b5 describe event or problem were updated.Completed information for section a1 patient identification: sid (b)(6).

Event Description

The customer observed a falsely elevated platelet result generated on the cell dyn ruby for one sample.The following data was provided: initial platelet result = 1486 k/ul, repeat = 300 k/ul additional laboratory data was provided: hemoglobin =10 g/dl, hematocrit = 24%.Further clarification was provided by the customer: (b)(6) 2022 sid (b)(6): platelet: ruby = 1486* 10e/ul (k/ul), repeat results on the sapphire = 386 10e3/ul.Additional laboratory data was provided: hemoglobin: ruby = 10.7* g/dl, repeat on the sapphire = 10.0 g/dl.The results generated on cell dyn ruby included a data invalidating flag.No impact to patient management was reported.

Manufacturer Narrative

The field service representative (fsr) inspected the instrument and replaced the solenoid valve assy.Return testing was not completed as returns were not available.A review of tracking and trending of the cell dyn ruby did not identify any trends associated with the complaint issue.A review of tracking and trending for the solenoid valve assy did not identify any trends.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and found to be adequate.Review of the specimen report generated on the cd ruby found that multiple parameters were flagged as suspect, results shown with an asterisk next to it, requiring further result validation.Multiple parameters, including the plt results, were displayed in purple and underlined indicating that the results exceeded the patient limit sets.Suspect population flags wbc, var lym, fragile wbc (fwbc)/ nonviable wbc (nwbc), dflt (nlmeb), rbc morph, mchc, and uri were generated indicating that verification of results may be required per the laboratory¿s protocol.The uri flag was generated indicating that there was an interference in the upper threshold region or plt aggregate count (plt clumps) > 15% of plt count.Per the cell-dyn ruby system operator¿s manual, 9212934g, that uri may be caused by: microcytic rbc, schistocytes, giant platelets, sickle cells, platelet clumps.Microcytic rbc, plt clumps, and increased numbers of giant plt are interfering substances of the plt parameters that may interfere with parameters and affect the results reported by hematology analyzer.It is also stated in the cell-dyn ruby system operator¿s manual, 9212934g, that when the fwbc flag displays, the operator should repeat the specimen using the cbc+noc test selection.Based on the available information, no systemic issue or deficiency of the cell dyn ruby for serial (b)(6) or the solenoid valve assy was identified.

• 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
• 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 ; 433331157
• MDR Report Key: 13281959
• MDR Text Key: 295334169
• Report Number: 2919069-2022-00001
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061667
• 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,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1