MAUDE Adverse Event Report: PERKINELMER, WALLAC OY NEOBASE NON-DERIVATIZED MSMS KIT; TANDEM MASS SPECTROMETRY ASSAY

Model Number 3040-001U

Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 perkinelmer received a complaint concerning the neobase non-derivatized msms test sys from the (b)(6) regarding a false negative screening result for a newborn who later confirmed for methylmalonic acidemia (mma).The newborn was born (b)(6) 2013, the newborn screening (nbs) specimen was taken at the age of 27 hours on (b)(6) 2013 and tested (b)(6) 2013.The reported results on (b)(6) 2013 indicated low risk to all screened disorders including mma.The specific primary marker for mma is acylcarnitine c3.At the age of 10 months the baby was referred to (b)(6) for eval due to clinical symptoms and mma diagnosis was confirmed by dna test.(b)(6) lab became aware of the baby's mma diagnosis on (b)(6) 2014.The (b)(6) lab retested the retained, original nbs specimen in 5 replicates.The measured c3 concentration for all the five replicates was elevated and indicated an elevated risk for mma.The (b)(6) lab filed a complaint with (b)(6) on (b)(6) 2014 and provided the results of original retests of the specimen for eval.We have confirmed with the (b)(6) lab that the newborn is responsive to vitamin b12-treatment.

Manufacturer Narrative

Mfg batch records were reviewed: no deviations were found, both original and retest device lots performed within acceptance range and the measured concentrations for c3 did not deviate from the other released kit lots.The data of customer's original test and retest were evaluated by biostatistician and customer support specialist: in both runs the device performance was acceptable, no deviations were identified and qc-control results were within +/- 1sd or +/- 2sd limits.Variation between 5 retest replicates were acceptable.The screening profiles of the original and retest were compared: significant differences between c3 and other analytes were observed.Based on the consistency of the 5 replicate results in retest, assay variation can be excluded as a cause for false negative result.Preventive maintenance of the test sys instruments (waters tqd msms) in customer lab had been completed on time, no reported problems with the instruments at the time of testing.Photo of the nbs specimen card provided by the (b)(6) lab shows that some of the original sample punches may have been incomplete i.E.Samples measured may have contained less blood.Through our analysis and investigation no malfunction or deficiency of product could be identified.Potential cause for false negative is that the samples in the retest were not from the same specimen as in the original test.The neobase non-derivatized msms test system is intended for the measurement and eval of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.Quantitative analysis of these analytes (list of analytes is extensive and can be provided upon request or refer to clearance letter for (b)(4)) and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.

• Brand Name: NEOBASE NON-DERIVATIZED MSMS KIT
• Type of Device: TANDEM MASS SPECTROMETRY ASSAY
• Manufacturer (Section D): PERKINELMER, WALLAC OY; turku 2010 1; FI 20101
• Manufacturer Contact: ann-christine fagerstrom, qual dir ; p.o. box 10; turku 20101 ; FI 20101 ; 22678111
• MDR Report Key: 4351053
• MDR Text Key: 5223163
• Report Number: 8043909-2014-00003
• Device Sequence Number: 1
• Product Code: NQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2014
• Device Model Number: 3040-001U
• Device Catalogue Number: 3040-001U
• Device Lot Number: 622128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 4