MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-17 for MEASLES IGG EIA 25181 manufactured by Bio-rad Laboratories.
[26807662]
On (b)(6) 2015, bio-rad laboratories technical support received a call from a customer to report that the (b)(6) was too low and the (b)(6) is also often too low. In investigating the issue, tech support obtained information from the customer that the customer manually modifies the run when the control wells fail by adding part of the contents of another well on that plate or another appropriately colored well found on another plate to the control well so that the well passes. Results were reported from these "modified" runs. Upon review of data sent by the customer, it was noted that the "modification" of the wells also took place in an additional four assays: monolisa anti-hbc eia, measles igg eia, mumps igg eia, and ortho hcv version 3. 0 elisa test system. Bio-rad laboratories sent a letter to the customer on 5/21/2015 informing them that the practice of "modifying " runs is an unacceptable laboratory practice and it was recommended that the customer repeat any samples whose results were reported on those modified runs and inform bio-rad laboratories if any incorrect results were reported. A second letter was sent informing them that all shipments will be suspended until the technician is re-trained on the evolis instrument by a bio-rad diagnostic support specialist. The customer was contacted two more times by bio-rad laboratories over phone to obtain information if incorrect results were reported. The customer had stated that they had sent a letter to the providers for the samples included in the 5/13/2015 monolisa anti-hav eia offering a no-charge repeat test for any sample result that did not agree with the clinical symptoms. The customer was also planning on sending the letters to providers for samples included in the 5/20/2015 monolisa anti-hav eia and the 5/13/2015 gs hbsag eia 3. 0 run. It is not known if the provider sent letters to providers for monolisa anti-hbc eia, measles igg eia, mumps igg eia, and ortho hcv version 3. 0 elisa test system. Results were released to the care providers by the customer and were likely released to the patients. Given the strong likelihood that incorrect results were reported, a mdr is being submitted for this case to each of the five assays we are responsible for reporting. Bio-rad laboratories does not have reporting responsibility for ortho hcv version 3. 0 elisa test system. The mdr will be evaluated by ortho for mdr reporting.
Patient Sequence No: 1, Text Type: D, B5
[114594524]
Follow-up #001 (originally submitted as 3022521-2015-00008 on 10/02/2015): upon further review of the laboratory data, bio-rad laboratories technical services noted and confirmed on 9/25/2015 that the customer did not modify the assay for measles igg eia. The mdr filing for measles igg eia was not necessary. This assay was the only one that was not modified by the customer, but a mdr was submitted. The customer did modify monolisa anti-hav eia, gs hbsag eia 3. 0 kit, monolisa anti-hbc eia, mumps igg eia, and ortho? Hcv version 3. 0 elisa test system. Description of event from 3022521-2015-00006: on (b)(6) 2015, bio-rad laboratories technical support received a call from a customer to report that the negative control for monolisa anti-hav eia was too low and the positive control for gs hbsag eia 3. 0 kit is also often too low. In investigating the issue, tech support obtained information from the customer that the customer manually modifies the run when the control wells fail by adding part of the contents of another well on that plate or another appropriately colored well found on another plate to the control well so that the well passes. Results were reported from these "modified" runs. Upon review of data sent by the customer, it was noted that the "modification" of the wells also took place in an additional four assays: monolisa anti-hbc eia, measles igg eia, mumps igg eia, and ortho? Hcv version 3. 0 elisa test system. Bio-rad laboratories sent a letter to the customer on 5/21/2015 informing them that the practice of "modifying " runs is an unacceptable laboratory practice and it was recommended that the customer repeat any samples whose results were reported on those modified runs and inform bio-rad laboratories if any incorrect results were reported. A second letter was sent informing them that all shipments will be suspended until the technician is re-trained on the evolis instrument by a bio-rad diagnostic support specialist. The customer was contacted two more times by bio-rad laboratories over phone to obtain information if incorrect results were reported. The customer had stated that they had sent a letter to the providers for the samples included in the 5/13/2015 monolisa anti-hav eia offering a no-charge repeat test for any sample result that did not agree with the clinical symptoms. The customer was also planning on sending the letters to providers for samples included in the (b)(6) 2015 monolisa anti-hav eia and the (b)(6) 2015 gs hbsag eia 3. 0 run. It is not known if the provider sent letters to providers for monolisa anti-hbc eia, measles igg eia, mumps igg eia, and ortho? Hcv version 3. 0 elisa test system. Results were released to the care providers by the customer and were likely released to the patients. Given the strong likelihood that incorrect results were reported, a mdr is being submitted for this case to each of the five assays we are responsible for reporting. Bio-rad laboratories does not have reporting responsibility for ortho? Hcv version 3. 0 elisa test system. The mdr will be evaluated by ortho? For mdr reporting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3022521-2015-00006 |
| MDR Report Key | 5084965 |
| Date Received | 2015-09-17 |
| Date of Report | 2017-06-28 |
| Date of Event | 2015-05-11 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2014-08-05 |
| Date Added to Maude | 2015-09-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID BHEND |
| Manufacturer Street | 6565 185TH AVE NE |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 4254981758 |
| Manufacturer G1 | QUEST INTERNATIONAL |
| Manufacturer Street | 8127 NW 29TH ST. #1 |
| Manufacturer City | DORAL FL 33122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEASLES IGG EIA |
| Generic Name | IVD, EIA |
| Product Code | LJB |
| Date Received | 2015-09-17 |
| Catalog Number | 25181 |
| Lot Number | G1004 |
| Device Expiration Date | 2015-07-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES |
| Manufacturer Address | 6565 185TH AVE NE REDMOND WA 98052 US 98052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-17 |