MAUDE Adverse Event Report: BAEBIES, INC. SEEKER

Device Problem False Positive Result (1227)

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

Event Date 12/21/2016

Event Type  malfunction  

Event Description

At the (b)(6) screening conference in the (b)(6) in september 2016, a newborn screening lab from (b)(6) reported results of a pilot study of newborn screening for lysosomal storage disorders (mps-1, pompe, fabry, pompe) using digital microfluidics fluorimetric assays provided by baebies, inc.(nc) in the talk they showed data to suggest that out of approx 10,000 newborn dried blood spots tested, they had a total of 4 screen positives (enzymatic activities below their chosen cutoff values).They showed genotype data showing that these were all false positives.People in attendance including me were surprised that they only had 4 false positives out of 10,000 given other studies with this platform and with tandem mass spectrometry.I have subsequently asked the lab in (b)(6)to provide the distribution of enzymatic activity plots, which i now have.They show clearly that the number of screen positives is about 280 out of 10,000 not 4.By comparison a recent pilot study with tandem mass spectrometry showed a 70-fold lower screen positive rate (molec.Genet.Metabol.2016, 118, 304-9.The distribution plots are available upon request from (b)(6).Also of concern is the reported %cv for the (b)(6) fluorimetric assays in the range up to 22% (for repeat analysis of the same dried blood spot on multiple plate readers.I am concerned that at the (b)(6) mtg, the author who presented the pilot studies gave a very inaccurate picture of the rate of screen positives.Also of concern is the high rate of screen positives (and thus false positives) of this digital microfluidics platform in this pilot study.

• Brand Name: SEEKER
• Type of Device: SEEKER
• Manufacturer (Section D): BAEBIES, INC.
• MDR Report Key: 6209105
• MDR Text Key: 63620725
• Report Number: MW5066928
• Device Sequence Number: 1
• Product Code: MVU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2016

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: Other
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1