MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE CS-2500; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number	CS-2500
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The cs-2500 operator's manual, chapter 8 - troubleshooting, section 8.5 - error message list, provides a listing of error messages for this instrument and their causes/corrective actions are as follows.The following information is provided for the errors generated by the sample analyses: 0032.0000.0000 [no coagulation]: possible cause: the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample or a reagent problem.Corrective actions/countermeasures: reanalyze and make a comprehensive judgment, taking sample and reagent, etc.Into consideration.Also, set a longer detection time and repeat the analysis.0032.0002.0000 [flat curve]: possible cause: the coagulation reaction was not detectable, due to low fibrinogen concentration, an anticoagulant sample, or a reagent problem.Corrective actions/countermeasures: reanalyze and make a comprehensive judgment, taking sample and reagent, etc.Into consideration.Also, set a longer detection time and repeat the analysis.When analysis is performed at a measurement time that exceeds the [check time] on the analysis preset tab screen, an analysis result is displayed as a numeric value with a flag.A field service engineer verified the analyzer and determined the analyzer performed as designed.The analyzer performed as designed by alerting the operator to possible sample abnormality requiring further verification of accurate results prior to reporting.A sample/patient specific abnormality, inadequate mixing, centrifugation or other mishandling of the samples could not be ruled out as contributing factors.No systemic product deficiency was identified.
Event or Problem Description
Multiple samples from the same patient were analyzed between (b)(6) 2019 and (b)(6) 2019.Most samples generated the "no coagulation" or "flat curve" errors with no numerical values for the prothrombin time (pt) results.The user reported pt results of >100 seconds.The patient was referred to another facility after (b)(6) 2019 and normal pt results were generated from subsequent samples.The patient received vitamin k treatment based on the erroneous pt results.It is unknown when the vitamin k treatment was administered.No patient harm was reported based on the administration of vitamin k.

• Brand Name: CS-2500
• Common Device Name: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 9454156
• Report Number: 1000515253-2019-00022
• Device Sequence Number: 3067296
• Product Code: JPA
• UDI-Device Identifier: 04987562433735
• UDI-Public: 0104987562433735
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K172286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CS-2500
• Device Catalogue Number: BV981798
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/11/2019
• 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: 75 YR