MAUDE Adverse Event Report: ABBOTT LABORATORIES ALINITY HS SLIDE MAKER STAINER MODULE; SLIDE STAINER, AUTOMATED

Catalog Number	09P69-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed no blast found from cellavision for one known blast cell patient on differential prepared by the alinity hs processing module.The cbc results generated from alinity hq processing module with blast flagging which matched the patient history.The pathologist questioned the different results due to not seen blast with known blast patient.The customer stated smear has no blast cell during reading from cellavision microscope.The customer noticed specimen dropped inside the instrument.The alinity hs processing module did not generate any flag for error message.The customer made manual differential and that confirmed blast cells in manual prepared smear.The customer agrees with manual differential results.The barcode id is correct on slide that made by the alinity hs processing module.The results provided were: (b)(6) 2024 sid (b)(6) wbc initial=30.1 10e3/ul; hemoglobin initial=7.56 g/dl; platelet initial=21.2 10e3/ul; differential with left shift, var lym and blast flags /no repeat results provided.Cellavision= no blast cell identified.Manual differential=blast=37 there was no reported impact to patient management.
Additional Manufacturer Narrative
A review of product historical data for any trends and all customer complaints received for this issue did not identify any trends or increase in complaint activity.Return testing was not completed as returns were not available.The customer provided flow cytometry standard (fcs) files, log files, specimen results, and images of the specimen tube and sample slide were submitted for review.Review of the data found seq 365083 generated a suspect flag for the lym, mono, and baso parameters.The sequence also generated a left shift, var lym, and blast flag for the sample.Review of the fcs files found the wbc scatter plot patterns to be abnormal, consistent with the flagged results produced.No algorithm issues were found.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the available information no product deficiency of the alinity hs processing module, serial number (b)(6), was identified.
Event or Problem Description
The customer observed no blast found from cellavision for one known blast cell patient on differential prepared by the alinity hs processing module.The cbc results generated from alinity hq processing module with blast flagging which matched the patient history.The pathologist questioned the different results due to not seen blast with known blast patient.The customer stated smear has no blast cell during reading from cellavision microscope.The customer noticed specimen dropped inside the instrument.The alinity hs processing module did not generate any flag for error message.The customer made manual differential and that confirmed blast cells in manual prepared smear.The customer agrees with manual differential results.The barcode id is correct on slide that made by the alinity hs processing module.The results provided were: (b)(6) 2024 sid (b)(6) wbc initial=30.1 10e3/ul; hemoglobin initial=7.56 g/dl; platelet initial=21.2 10e3/ul; differential with left shift, var lym and blast flags /no repeat results provided.Cellavision= no blast cell identified.Manual differential=blast=37 there was no reported impact to patient management.

• Brand Name: ALINITY HS SLIDE MAKER STAINER MODULE
• Common Device Name: SLIDE STAINER, AUTOMATED
• 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: 20075336
• Report Number: 2919069-2024-00049
• Device Sequence Number: 6573809
• Product Code: KPA
• UDI-Device Identifier: 00380740138868
• UDI-Public: (01)00380740138868
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 09P69-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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