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	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased hemoglobin results for two patients on a cell-dyn sapphire analyzer.The following data was provided: sample id (b)(6) initial result was 4.7 mmol/l, which was released to the physician.The sample was repeated, on another cell-dyn sapphire analyzer, and the result was 5.6 mmol/l, which the customer believes is the correct result for this patient.Sample id (b)(6) initial result was 4.7, repeat result was 5.1 mmol/l the customer stated that because of the low hemoglobin result for sample id (b)(6), the patient was given a blood transfusion; however, the repeat result for this patient, which was deemed correct by the customer, was also a low hemoglobin result.There was no reported impact to the patient due to the transfusion.There was no other impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 - patient identifier complete entry = sample id (b)(6) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased hemoglobin results for two patients on a cell-dyn sapphire analyzer.The following data was provided: sample id (b)(6) initial result was 4.7 mmol/l, which was released to the physician.The sample was repeated, on another cell-dyn sapphire analyzer, and the result was 5.6 mmol/l, which the customer believes is the correct result for this patient.Sample id (b)(6) initial result was 4.7, repeat result was 5.1 mmol/l the customer stated that because of the low hemoglobin result for sample id (b)(6), the patient was given a blood transfusion; however, the repeat result for this patient, which was deemed correct by the customer, was also a low hemoglobin result.There was no reported impact to the patient due to the transfusion.There was no other impact to patient management reported.
Additional Manufacturer Narrative
An abbott field service representative (fsr) was dispatched due to the customer reporting falsely decreased hemoglobin results on the cell-dyn sapphire analyzer, serial number (b)(6).Through an extensive investigation, the fsr found a piece of rubber in the tubing between the hgb dilution cup and hgb flow cell was found partially obstructing fluid flow.Due to the partial obstruction, the hgb dilution cup was not fully drained before processing the next sample.This residual fluid caused dilution of the next sample, thus generating lower hgb results.The fsr removed the obstruction, which solved the problem.No subsequent issues have been reported.A review of the instrument history revealed no contributing factors described in this complaint.A review of labeling and historical data was done, and both were adequate, with no trends found.Based on all available information and abbott diagnostics' complaint investigation, no systemic issue or product deficiency was identified.

• 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: 19856134
• Report Number: 2919069-2024-00046
• Device Sequence Number: 17990717
• Product Code: GKZ
• UDI-Device Identifier: 00380740016616
• UDI-Public: (01)00380740016616
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 07/10/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2017
• 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