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

Catalog Number 08H67-01

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2016

Event Type  malfunction  

Manufacturer Narrative

Patient id number does not fit due to field character limitation.The full patient id is (b)(6).This event was reviewed by the abbott diagnostics division medical director.His assessment of the event concluded that the incorrect wbc result did not cause nor contribute to this patient's death.The wbc result did not change treatment.Per the complainant, the wbc result did not contribute to the patient's death.The cause of death was heart failure.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer stated that a patient was emergency transferred to the customer site on (b)(6) 2016.No patient history was provided except that the patient had many disease states including pulmonary congestion, liver congestion and kidney stones.A complete blood count (cbc) was performed on the cell-dyn ruby analyzer.The patient's wbc results were 21.8 and 21.5 k/ul with invalid data flagging generated.The invalid wbc result of 21.8 k/ul was reported out of the laboratory prior to manual slide review.Manual slide review was later performed and the wbc count was estimated to be approximately 3.0 k/ul.The customer stated that the patient was not treated based on the falsely elevated result.The customer mentioned that the patient died in the morning on (b)(6) 2016 due to heart failure.The customer stated that the cell-dyn ruby wbc result did not impact patient treatment and did not contribute to the patient's death.

Manufacturer Narrative

Investigation consisted of review of submitted data, product labeling and product historical data.Review of product historical data did not identify any adverse trends or abnormal complaint activity for the complaint issue.All submitted data was reviewed.As recommended per the cell-dyn ruby system operator's manual, the submitted data showed that the samples required further verification before reporting outside the laboratory.Based on the submitted data, the cell-dyn ruby analyzer was performing as designed when presented with a sample which contains interfering substances and conditions.The analyzer generated dispersional data alerts, suspect population flags, suspect parameter flags, and interpretive messages to alert the operator for needed verification of results as stated in the cell-dyn ruby system operator's manual.The complaint incident was a sample-specific issue.A product deficiency was not identified for the cell-dyn ruby analyzer, list number 08h67-01.

• 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: 6246077
• MDR Text Key: 64737722
• Report Number: 2919069-2017-00002
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: 00380740017170
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/19/2017

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 Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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