MAUDE Adverse Event Report: CHASKA DISCRETE MFG IO ACCESS FERRITIN; RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN

Model Number 33020

Device Problem Low Test Results (2458)

Patient Problem No Code Available (3191)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

Customer did not provide patient demographics such as date of birth, sex, weight, ethnicity or race.The access ferritin reagent was not returned for evaluation.A beckman laboratory system support (lss) was dispatched to the customer's site and performed a dilution test for the questioned sample on (b)(6) 2019 and the test result of the diluted sample was > 75000.0 ng/ml.The cause of this isolated event cannot be determined.Beckman coulter internal number: (b)(4).

Event Description

The customer reported low ferritin results for one patient sample.The result was generated on the laboratory's unicel dxi 800 access immunoassay system (serial number (b)(4)).The initial elevated ferritin result was released from the laboratory and the report was sent to the patient.The patient received treatment based on the initial result on (b)(6) 2019.The details of the treatment were not provided.The patient¿s dosage of medication was adjusted after reporting of the second lower result on (b)(6) 2019.The details of the treatment were not provided.The patient was sent for emergency care.On (b)(6) 2019, the patient was diagnosed with hemophagocytic syndrome.The customer did not report any additional change or impact to patient care or treatment in association with this event.The customer reported that quality control (qc), calibration and system check were performing within assay and instrument specifications at the time of the event.Information on the collection and processing of the patient sample is not available.No issues with sample integrity were reported.

Manufacturer Narrative

Additional information provided on april 29th, 2019 from customer: on (b)(6) 2019, 23 month old child, the patient went to out-patient due to fever and rash.The patient had fever for two weeks.The patient took the dexamethasone, cephalosporin as the anti-infective treatment in local hospital, however, the patient was not getting better.Then, the patient was transferred to (b)(6) hospital.The test result of ferritin was 1170 ng/ml and the test result of esr was 93 at that moment.On (b)(6) 2019, the test result was 8596 ng/ml, the patient was performed anti-infective treatment and antiviral treatment.On (b)(6) 2019, took the dexamethasone 5 mg/ day.On (b)(6) 2019, the test result of ferritin was 1102 ng/ml, however, the symptom of patient was severely bad, and the patient was sent to emergency care.On (b)(6) 2019, the test result of ferritin was >1500 ng/ml and the test result of diluted sample was >30000 ng/ml.The clinic doctor made the diagnosis of hlh, and thought that the test result on (b)(6) 2019 was erroneously low.Then, the sample on (b)(6) 2019 was diluted and the test result was >70000 on the repeated run.Treatment, on (b)(6) ciclosporin, methylprednisolone treatment.On (b)(6), decreased the dosage of methylprednisolone, and remained the rest medicine dosage.On (b)(6), the vital sign was stable.On (b)(6) 2019, the patient was discharged from hospital with medicine description.¿ diagnosis was made via hlh (b)(6) diagnosis and treatment guidance." beckman coulter internal number: case-(b)(4).

• Brand Name: ACCESS FERRITIN
• Type of Device: RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN
• Manufacturer (Section D): CHASKA DISCRETE MFG IO; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 8394289
• MDR Text Key: 137943521
• Report Number: 2122870-2019-01051
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 15099590575052
• UDI-Public: (01)15099590575052(17)190731(11)190731(10)831328
• Combination Product (y/n): N
• PMA/PMN Number: K052082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 33020
• Device Catalogue Number: 33020
• Device Lot Number: 831328
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 MO