CEP 8 (D8Z2) SPECTRUMGREEN PROBE 06J37-18

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-03-25 for CEP 8 (D8Z2) SPECTRUMGREEN PROBE 06J37-18 manufactured by Abbott Molecular, Inc..

Event Text Entries

[17131848] Background: the cep 8 spectrumgreen (sg) asr probe kit, 20ul (list 06j37-018) is an analyte specific reagent (asr) containing a single vial of cep 8 spectrum green probe and a certificate of analysis (coa). Chromosome enumeration probes (cep) are chromosome-specific fish probes that hybridize to highly repetitive human satellite dna sequences, usually located near centromeres. Cep signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for cep 8 sg asr probe kit indicates it is an analyte specific reagent, and analytical and performance characteristics are not established. Issue: a customer received five kits of cep 8 sg asr probe (list 06j37-018, lot 440023), containing vysis cep 4 (alpha satellite) sg probe, 20ul, (part 32-112004, lot 438814) instead of the expected cep 8 probe. The customer did not use the kits containing the incorrect component. Abbott molecular sent replacement kits to the customer. The customer returned the five kits containing incorrect components to abbott molecular. Impact: product functionality is impacted because use of cep 4 (sg) would not accurately enumerate chromosome 8. The cep 8 sg probe and the cep 4 sg probe both produce green signals near the centromere of their respective chromosomes. The presence of spectrum green signals near the centromere may lead the technician to conclude the test was performed correctly. If cep 8 positive controls are not run with patient samples, then the potential exists to generate incorrect results. Note: the cep 4 probe vials were correctly labeled to identify the actual contents of cep 4 probe.
Patient Sequence No: 1, Text Type: D, B5


[17321399] An abbott molecular investigation confirmed this issue as a product malfunction. (b)(4) capa was opened as a result of this malfunction issue and is in progress. An mdr follow-up report will be submitted after the 556-capa investigation reaches a conclusion. Abbott molecular is preparing an 806 field action to notify affected customers. Previously reported mdrs related to this same malfunction issue: 3005248192-2013-00005; 3005248192-2013-00006; 3005248192-2013-00007.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005248192-2013-00008
MDR Report Key3019748
Report Source07
Date Received2013-03-25
Date of Report2013-02-28
Date of Event2013-02-28
Date Mfgr Received2013-03-05
Device Manufacturer Date2013-03-07
Date Added to Maude2013-05-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactJEAN LEETE
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone2243617274
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal Code60018
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCEP 8 (D8Z2) SPECTRUMGREEN PROBE
Generic NameANALYTE SPECIFIC REAGENTS
Product CodeMVU
Date Received2013-03-25
Returned To Mfg2013-03-06
Catalog Number06J37-18
Lot Number440023
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-03-25

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