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

Model Number 08H67-01

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient received salinoferesis.An evaluation is in process.A followup report will be submitted when the evaluation is complete.

Event Description

The account stated a newborn patient received salinoferesis due to elevated hematocrit results generated on the cell-dyn ruby.The account stated that although the patient had symptomatic polyglobulia, the treatment was unnecessary.The patient was discharged with follow-up checks a few days later.Patient gender was not provided.Patient 7 ((b)(6)): (b)(6) 2017 hct of 64.7%, (b)(6) 2017 hct of 54.1%, (b)(6) 2017 hct of 32.3%.Diagnosis: preterm newborn, (b)(6) months of gestation, potentially infected by the mother with vaginosis, bacteriana and gastroenteritis, hyaline membrane disease, 1 dose of surfactant, asymptomatic polycythemia, salinoferesis, barely premature, suction disorder.

Manufacturer Narrative

Field service visited the site on (b)(6) 2017 and ran fl/cal, controls and blood samples.On (b)(6) 2017 field service visited the site again.Controls were within specification, and the blood samples run on the cell-dyn ruby and roche instruments gave hct values of 60% which was close to the cases reported.Additionally, medical affairs reviewed the complaint text and determined that the newborns physiologically have high hgb, hct and mcv values.The reported hct value was above the expected range only for one patient, however the rbc and hgb values were equivalent on the two instruments.The difference in the hct values originated from the difference in mcv.The cell-dyn ruby reported an mcv of 104 fl, while the other analyzer (roche) reported an mcv of 94.8 fl.The difference between these values is larger than expected based on potentially different technology and calibration.However, both values are within physiological range for mcv (for newborns).The discrepancy between the hct values should be confirmed by the reference method (icsh) which is a spun hematocrit; however, reference hct (spuncrit) was not available; therefore, it is not possible to conclude which instrument was more accurate.Hct values fall after birth, so the drop that was seen in these patients was also not unexpected and does not mean that the instrument did not give an accurate hct the first time.Based on the available information, a discrepancy in mcv values was observed between the instruments.Results reported by the cell-dyn ruby were within normal range, and the qc results were also in range; therefore, instrument malfunction could not be concluded.Additionally, the cell-dyn ruby generated dispersional data alerts and flags to alert the operator for the presence of abnormal cell populations which required verification.A review of the product labeling concluded that the issue is sufficiently addressed.A historical data review was performed for the cell-dyn ruby with no issue found during the 12 month search period.Based on the investigation, no product deficiency was identified for the cell-dyn ruby.

• 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
• MDR Report Key: 7180916
• MDR Text Key: 97858770
• Report Number: 2919069-2018-00008
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00380740017170
• UDI-Public: (01)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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08H67-01
• Device Catalogue Number: 08H67-01
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability