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

Catalog Number K1023 SMN 10445160

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Siemens healthcare diagnostics has confirmed that dimension vista® calcium (ca) flex® reagent cartridge lot 17171bd may produce erroneously low results from specific well sets.If ca reagent calibration is performed using an unaffected well set and qc and patient samples are subsequently processed using an affected well set, ca results may be falsely depressed up to -2.8 mg/dl (-0.7 mmol/l).If ca reagent calibration is performed using an affected well set, and qc and patient samples are subsequently processed using an unaffected well set, ca results may be falsely elevated.The observed bias for serum, plasma, and urine specimens are similar.Urgent medical device recall, vc-18-03.A.Us and urgent field safety notice vc-18-03.A.Ous dated january, 2018 were issued to customers who had been shipped dimension vista® calcium (ca) flex® reagent lot 17171bd.Customers were instructed to discontinue use and to discard lot 17171bd.

Event Description

Discordant imprecise and out of range calcium (ca) results were obtained on quality control samples on the dimension vista 1500 instrument s/n (b)(4).The customer stated there was no impact on the patient results.There is no known report of any delays in reporting, patient intervention, or adverse health consequences due to the discordant imprecise and out of range ca qc results.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® CA CALCIUM FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 7278567
• MDR Text Key: 100513146
• Report Number: 2517506-2018-00110
• Device Sequence Number: 1
• Product Code: CIC
• UDI-Device Identifier: 00842768015618
• UDI-Public: 00842768015618
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K061792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2018
• Device Catalogue Number: K1023 SMN 10445160
• Device Lot Number: 17171BD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-02/01/2018-001-R
• Patient Sequence Number: 1