MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-12-12 for NEOBASE NON-DERIVATIZED MSMS KIT 3040-001U manufactured by Perkinelmer, Wallac Oy.
[5223163]
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.
Patient Sequence No: 1, Text Type: D, B5
[12699430]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043909-2014-00003 |
| MDR Report Key | 4351053 |
| Report Source | 07 |
| Date Received | 2014-12-12 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-05-02 |
| Date Mfgr Received | 2014-11-17 |
| Device Manufacturer Date | 2013-01-30 |
| Date Added to Maude | 2015-01-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN-CHRISTINE FAGERSTROM, QUAL DIR |
| Manufacturer Street | P.O. BOX 10 |
| Manufacturer City | TURKU 20101 |
| Manufacturer Country | FI |
| Manufacturer Postal | 20101 |
| Manufacturer Phone | 22678111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOBASE NON-DERIVATIZED MSMS KIT |
| Generic Name | TANDEM MASS SPECTROMETRY ASSAY |
| Product Code | NQL |
| Date Received | 2014-12-12 |
| Model Number | 3040-001U |
| Catalog Number | 3040-001U |
| Lot Number | 622128 |
| Device Expiration Date | 2014-01-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERKINELMER, WALLAC OY |
| Manufacturer Address | TURKU 20101 FI 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-12 |