|
Possible catalog and lot numbers were reported by customer, as they were unsure of exact catalog and lot numbers involved.The information for each is as follows: catalog #: 367884, (b)(4).Medical device lot #: 7157803, medical device expiration date: 10/31/2018, device manufacture date: 06/06/2017.Medical device lot #: 7067973, medical device expiration date: 07/31/2018, device manufacture date: 03/8/2017.Medical device lot #: 7067974, medical device expiration date: 07/31/2018, device manufacture date: 03/08/2017.Medical device lot #: 7033669, medical device expiration date: 06/30/2018, device manufacture date: 02/02/2017.Medical device lot #: 7033670, medical device expiration date: 06/30/2018, device manufacture date: 02/02/2017.Catalog #: 366664, (b)(4).Medical device lot #: 7033560, medical device expiration date: 06/30/2018, device manufacture date: 02/02/2017.Medical device lot #: 6342639, medical device expiration date: 04/30/2018, device manufacture date: 12/07/2016.Medical device lot #: 7067758, medical device expiration date: 07/31/2018, device manufacture date: 03/08/2017.Catalog #: 367886, (b)(4).Medical device lot #: 7100984, medical device expiration date: 09/30/2018, device manufacture date: 04/10/2017.(b)(6).Investigation: this mdr is one of a total of 286 mdrs filed for complaints received on bd vacutainer® lithium heparin tubes.Elevated results were reported on a total of 286 patients, therefore one mdr is being submitted per patient.Bd vacutainer® lithium heparin tubes are single use tubes used to collect, transport and process venous blood specimens to obtain plasma for testing in the clinical laboratory for in vitro diagnostic use.Abnormal cohb (carboxyhemoglobin) results have been reported when using venous blood gas samples collected with bd vacutainer® plastic non-gel lithium heparin tubes, and analyzed with the il gem 4000 instrument.Cohb is formed in red blood cells when carbon monoxide is inhaled and is measured to assess for suspected carbon monoxide poisoning.Bd recommends the use of the bd a-line¿ arterial blood collection syringe for cohb determinations as outlined in the ifu.Bd has followed up with the customer to obtain further detail.The customer confirmed that of the patients with falsely elevated results, none were treated.The patients who were considered ¿true¿ positives had significantly higher results, matched the clinical presentation of increased cohb, and were subsequently treated with oxygen therapy.Bd has conducted further investigation to compare cohb results using the bd vacutainer® lithium heparin tubes and bd a-line¿ arterial blood collection syringes.Bd received samples of tubes from the incident lots from the customer facility for investigation.The customer samples were evaluated along with retention samples of the incident lots selected from bd inventory.Additionally, retention samples of the a-line¿ syringe were selected from bd inventory for testing.The investigation concluded the following: the 4 ml bd vacutainer ® lithium heparin tube is clinically equivalent to the bd a-line¿ syringe for cohb when tested on both the iil gem®4000 and the radiometer abl.The 2 ml bd vacutainer ® lithium heparin tubes (2 lots) are clinically equivalent to the bd a-line¿ syringe for cohb when tested on the radiometer abl.However, when tested on the il gem® 4000, results demonstrate a clinically significant positive bias resulting in clinical non-equivalence to the a-line¿ syringe.On both instruments, all blood collection tubes demonstrated a positive bias for cohb compared to the control a-line¿ syringe, with the magnitude of the bias greater for 2 ml tubes (versus 4 ml).These results are consistent with data from the poster presented by il at aacc 2013 ¿carboxyhemoglobin- pre- analytical errors from blood collection devices"[1].A review of the device history record was completed for the incident lots and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Collection of blood for testing of carboxyhemoglobin (cohb) in a partial draw lithium heparin tube (2.0 ml) can lead to false positive results.A false positive result would only mean that the patient would continue to be treated with 100% o2 for a longer period.There is no risk to the patient from this extended treatment, except in the case of hyperbaric oxygen therapy.This is the preferred treatment for pregnant women.Therefore, the health risk associated with the product is considered limited, due to the nature of the situation, according to our health hazard evaluation conducted by medical affairs.A capa has been initiated to document further investigation and root cause analysis relating to this issue.The investigation is currently on-going and will be updated as the potential root cause(s) are identified.[1] pamidi p, yim h.Carboxyhemoglobin-preanalytical errors from blood collection devices.Instrumentation laboratory, bedford ma.Aacc poster session 2013.
|
