MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE

Catalog Number K1023 SMN 10445160

Device Problem Low Test Results (2458)

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

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

Analysis of the instrument and instrument data indicate that the cause for the discrepant low ca qc and patient results is unknown.Siemens healthcare is investigating calcium (ca) lot 16060bb.The mdr will be updated with the results of the investigation.

Event Description

The customer stated calcium (ca) patient results dropped low on the dimension vista instrument.Qc was run and was out of range low.Patient results were reported prior to qc being detected out of laboratory ranges.Patient results were not questioned by physicians.Patients samples were retested on an alternate vista instrument and higher results were recovered.Corrected reports were issued.There is no indication that patient treatment was altered or prescribed on the basis of discrepant low ca results.There was no report of adverse health consequences as a result of discrepant low ca results.

Manufacturer Narrative

Original mdr was filed 2016-06-27.Analysis of the instrument and instrument data indicate that the cause for the discrepant ca results is related to a flex reagent cartridge well set issue.The low results were obtained from a single well set.Siemens healthcare diagnostics has completed an investigation of calcium (ca) flex reagent cartridge lot 16060bb.It has been confirmed that dimension vista calcium (ca) flex reagent cartridge lot 16060bb may produce erroneously low results from specific well sets.If calibration is performed using an unaffected well set and samples are subsequently run using an affected well set, ca results may be falsely depressed up to -2.9 mg/dl (-0.72 mmol/l).Bias for serum, plasma, and urine specimens are similar.If calibration is performed using an affected well set, ca results for patient and qc samples from subsequent unaffected well sets may be falsely elevated.An urgent medical device recall communication, vc-16-05.A.Us, and an urgent field safety notice, vc-16-05.A.Ous dated august 9, 2016 was issued to customers who had been shipped lot 16060bb.Customers were instructed to discontinue use and to discard the lot.Siemens offered a no charge replacement for discarded reagent.

• Brand Name: DIMENSION VISTA® CALCIUM FLEX® REAGENT CARTRIDGE
• Type of Device: DIMENSION VISTA® CA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 5750493
• MDR Text Key: 48214631
• Report Number: 2517506-2016-00270
• Device Sequence Number: 1
• Product Code: CIC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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
• Device Operator: Medical Technologist
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 16060BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2517506-08-15-2016-002-R
• Patient Sequence Number: 1