MAUDE Adverse Event Report: SYSMEX CORPORATION CS-2100I; AUTOMATED BLOOD COAGULATION ANALYZER

Model Number CS-2100I

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

The cs-2100i 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.The following information is provided for the errors generated by the sample analysis: 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.The patient's sample generated a low fibrinogen result, however no reference range was provided.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 sample could not be ruled out as contributing factors.No systemic product deficiency was identified.

Event Description

The sample, collected from a patient in (b)(6), was analyzed and generated a "no coagulation" error with no numerical values for the prothrombin time (pt) results.The sample was repeated multiple times with the same result.The user reported a pt result of "no coagulation" to the clinician.The sample was analyzed on a different analyzer and the pt result generated was within normal range.The patient was administered fresh frozen plasma (ffp) based on the erroneous pt result.No patient harm was reported based on the administration of ffp.

• Brand Name: CS-2100I
• Type of Device: AUTOMATED BLOOD COAGULATION ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer (Section G): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 9497487
• MDR Text Key: 174206523
• Report Number: 1000515253-2019-00023
• Device Sequence Number: 1
• Product Code: JPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS-2100I
• Device Catalogue Number: 06372511
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR