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

Catalog Number	08H00-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased wbc results generated on the cell-dyn sapphire analyzer for two patients.The customer stated there was no flags on the wbc results.The samples were repeated and normal results were obtained.The following data was provided: initial wbc results = 1 x 10e3/ul.Repeat wbc result = normal.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased wbc results generated on the cell-dyn sapphire analyzer for two patients.The customer stated there was no flags on the wbc results.The samples were repeated and normal results were obtained.The following data was provided: initial wbc results = < 1 x 10e3/ul.Repeat wbc result = normal.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) went on-site to inspect the instrument.An air bubble in the yellowish peristaltic pump tubing (ppt) may have led to the falsely decreased wbc result.The fsr replaced the peristaltic pump tubing.A review of tracking and trending of the product list number and complaint activity did not identify any trends for cell-dyn sapphire instrument with regards to the current issue.The device history records were reviewed, and no non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the cell-dyn sapphire for serial number (b)(6) was identified.The following sections have been corrected to reflect the current contact (b)(6): g1-contact office first name.G1-contact office last name.G1-contact office address 1 g1-contact office city g1-contact office postal code g1-contact office country g1-contact office phone number g1-contact office email g1-contact office fax number.

• Brand Name: CELL-DYN SAPPHIRE SYSTEM
• Common Device Name: 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: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 17843533
• Report Number: 2919069-2023-00030
• Device Sequence Number: 4350070
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: 00380740016616
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 08H00-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 11/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown