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 Problems Death (1802); Misdiagnosis (2159)

Event Date 10/25/2015

Event Type  Death  

Manufacturer Narrative

The customer provided no returns and no additional information for this evaluation.A historical product data review was performed for the analyzer and a historical review of complaints as well as a review of adverse events for the cell-dyn ruby analyzer.No similar events were found.A product issue was not identified for the cell-dyn ruby analyzer.The cell-dyn ruby system operator's manual provides information to address the current customer issue.The information from the customer site indicates that the results (particularly the hemaglobin and platelets) were due to the patient's condition (bleeding) and the transfusion given.However, due to the lack of information provided, it cannot be completely ruled out that the cell-dyn ruby analyzer did impact patient management and could have caused/contributed to the patient's death.The analyzer did flag results, which should have been acted upon further before reporting the results from the lab as indicated in the cell-dyn ruby system operator's manual.In this regard, a use error is identified.(b)(4).

Event Description

The customer reports that a (b)(6) pregnant female patient was seen in the emergency department and generated a hemoglobin result of 9.780 g/dl with a wbc count of 42.03 k/ul on a cell-dyn ruby analyzer.The patient was referred to a general surgeon because of the elevated wbc count and because an ultrasound found fluid around the liver with evidence of bleeding.A second blood sample taken (approximately 8 hours later) generated a hemoglobin result of 4.753 g/dl, which correlated to blood gas results.A blood transfusion was given and a third sample taken approximately two hours later generated a hemoglobin result of 7.193 g/dl.The female patient and fetus died as a result of the bleeding with cause of death cited as disseminated intravascular coagulation.The following is a chronology of results provided by the customer: date/time:(b)(6) 2015 11:33: hgb= 9.780, sn: (b)(4); date/time:(b)(6) 2015 19:48: hgb= 4.753, sn: (b)(4); date/time:(b)(6)2015 21:42: hgb= 7.193, sn: (b)(4); date/time:(b)(6) 2015 23:15: hgb= 2.287, sn: (b)(4); date/time:(b)(6) 2015 01:30: hgb= 1.321, sn: (b)(4); date/time:(b)(6) 2015 02:03: hgb= 7.087, sn: (b)(4).Hgb= hemoglobin in g/dl; customer reference range: 10.8-14.2.The customer would not disclose the condition of the patient and the treatments administered during the above timeframes.In all the runs documented, the hemoglobin results were flagged, indicating that additional verification was needed; however, no data was provided to confirm if repeat runs or smear reviews were performed.Quality controls samples were within specifications on all runs.

• 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: 5299420
• MDR Text Key: 37333638
• Report Number: 2919069-2015-00089
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• 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: 11/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2013
• 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 Outcome(s): Death
• Patient Age: 32 YR