MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-10
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial analysis of sid (b)(6) was judged "positive" with ip message "anemia" alerting to sample abnormality.The sysmex xn-3000 instructions for use (ifu), chapter 11 - checking detailed analysis information (data browser), section 11.6 - ip messages, details the method in which the analyzer conveys its findings.Results without an error message are categorized as "positive" or "negative" based upon preset criteria, some of which are laboratory-defined.The system bases judgments on comprehensive surveys of numerical data, particle-size distributions, and scattergrams.Flags and messages, communicated through ip messages, indicate the analyzer's findings and notify of possible sample specific abnormalities.Further verification of accurate results is recommended prior to reporting to the clinician.A sysmex technical services quality solutions manager (tsqsm) advised the user to perform a precision study.Sid (b)(6) was analyzed three times, twice in the sampler mode and once in the manual mode.The second analysis in the sampler mode generated a function error, and the results were suppressed [----].This indicated the initial sample volume was borderline acceptable for proper aspirations.Chapter 9 - analyzing samples, section 9.2.1 - sample types and handling, states the required sample volume for analysis in the sampler mode is 1 ml.A sysmex service engineer (se) was dispatched to verify the container type service setting.The se arrived on site on 10/01/2020 and found the container type setting was set to sarstedt instead of normal.The setting was changed to normal and the piercer alignment verified.Sarstedt tubes are not used by the laboratory.Analyzer performance was verified by the processing all levels of the customer's quality control.All parameters of all levels were within manufacturer's assay and within the customer's established ranges.It is unknown how or when the container type was modified.The tsqsm determined the low sample volume and incorrect setting contributed to the event.No analyzer deficiency was identified.
Event or Problem Description
A user in (b)(6) reported a patient was administered an unnecessary packed red blood cell (prbc) transfusion.The sample tube contained approximately 1 ml of sample and was analyzed in the sampler mode.The sample was judged "positive" with an interpretive program (ip) message alerting the user to sample abnormality.An erroneously low hemoglobin (hgb) result was generated.The result was released to the laboratory information system (lis).Based on the erroneously low hgb result, two units of prbcs were transfused.A post transfusion sample was analyzed, generating a hgb result inconsistent with the amount of prbcs transfused.The first sample was reanalyzed, and a higher hgb result was obtained.No patient harm was incurred due to the transfusion.

• Brand Name: XN-10
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 10644426
• Report Number: 1000515253-2020-00028
• Device Sequence Number: 19558553
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)171107
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112605
• 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
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR